Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its Inquiry Steerable Diagnostic Catheters [Model: IBI 81104 (Batch: 7397352, GTIN: 05414734302975); IBI 87002 (Batch: 7397307, GTIN: 05414734309936)].

As a result of a manufacturing error, these two models/batches were mislabeled. Packages labeled for Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Correspondingly, packages labeled Model IBI-87002, batch 7397307 incorrectly contained Model IBI-81104, batch 7397352. The differences between the two models are summarized in the following:

Model IBI-81104 [10 Electrodes; Size 6F; Curve L; Compatible Cable: 1910-Cable (Model: IBI-85954)]

• Catheter is for coronary sinus placement to provide coronary sinus reference. Typically used for pacing, capturing signals, mapping system reference, and location of the other catheters used during the procedure. Generally used for all electrophysiology procedures. Typically utilized over a venous vascular access.

Model IBI-87002 [14 Electrodes; Size 5F; Curve L1/ XL1; Compatible Cable: 1914-Cable (Model: IBI-85945)]

• Catheter has additional electrodes and wider spacing for reference electrode. Typically placed in coronary sinus and up the lateral wall in the right atrium. Additional data can be captured due to the wider spacing. The most proximal electrode is used as a reference in the inferior vena cava. Typically utilized over a venous vascular access.

Both cable models utilize the same connector. Compatibility is only related to the number of active signals supported by the cable to the catheter.

During setup, if the physician fails to observe the difference in the catheters, the intracardiac electrograms will not be representative of the desired signals due to the difference in the number of electrodes and electrode spacing between the 14-electrode catheter and the 10-electrode catheter. The risk of patient harm is low and is limited to risks associated with a delay in procedure. There have been six customer reports of nonconforming devices, none of which were associated with patient harm.

According to the manufacturer, affected lots should not be used and unused affected products should be returned to the manufacturer.

According to the local supplier, the affected products are not distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 28 August 2020