The investigation was completed on 01-nov-2023.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed a hole on the pebax with internal parts exposed.The device was connected to 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.The root cause of the hole in the pebax 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.The damage on the pebax could be related to the reported event.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.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: material and/or chemical problem identified (c06) / investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the biosense webster inc.Analysis finding of the ¿hole on the pebax with internal parts exposed¿ and the customer¿s reported ¿force sensor error¿.-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¿.Manufacturer's reference number: (b)(4).
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It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax with internal parts exposed.The carto 3 system displayed error 106, force sensor error.The cable was replaced without resolution.The thermocool® smart touch® sf bi-directional navigation catheter was replaced and the issue resolved.The procedure continued.There was no patient consequence reported.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 01-nov-2023 observed a hole on the pebax with internal parts exposed.This event was originally considered non-reportable, however, bwi became aware of a hole on the pebax with internal parts exposed on 01-nov-2023 and have assessed this returned condition as reportable.
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