It was reported that a patient underwent a atrioventricular nodal reentrant tachycardia (avnrt) procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a cut on the pebax and internal parts exposed.Initially it was reported that the carto 3 system displayed a force sensor error (error code 106) when the catheter was connected to the patient interface unit (piu).They reseated the catheter but the issue persisted.The cable was replaced without resolution.The catheter was replaced and the issue was resolved.The procedure was continued.No patient consequence reported.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2023, there was a cut on the pebax with reddish-brown material inside and internal parts exposed.This event was originally considered non-reportable, however, bwi became aware of a cut on the pebax and internal parts exposed on (b)(6) 2023 and have assessed this returned condition as reportable.
|
The device evaluation was completed on (b)(6) 2023.The device was returned to biosense webster (bwi) for evaluation.Visual inspection, and screening tests of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed a cut on the pebax with reddish-brown material inside and internal parts exposed; however, the cut could be related to the handling since in the process there are control inspection points to avoid this kind of issue; however, this could not be conclusively determined.Then the device was connected to the carto 3 system, and the device was visualized and recognized correctly; however, error 106 appeared on the system due to an open circuit on the tip area.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.The force issue reported by the customer was confirmed; however, the reddish material is not related to the customer complaint.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the biosense webster inc.Analysis finding of the ¿cut on the pebax with reddish-brown material inside and internal parts exposed¿.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the customer¿s reported ¿force sensor error (error code 106)¿.Manufacturer's reference number: (b)(4).
|