MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE; INTRODUCER, CATHETER

Catalog Number	301803MS
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation (b)(6) 2023.The device evaluation was completed on (b)(6) 2024.The product was returned to biosense webster for evaluation.It was sent to the device manufacturer for further investigation.Visual and functional analysis of the returned device were performed following bwi procedures.Visual inspection of the device revealed a superficial damage in the shaft at the end of the vessel dilator.A device history record evaluation was performed and no internal actions related to the complaint were found during the review.The complaint reported by the customer was confirmed, as it was observed that a resistance condition was felt on the perforation observed, when the functional analysis was performed using the cordis lab needle and the guidewire applicable, as the guidewire and needle were getting stuck in the affected zone of the perforation.The condition described before could be related to the event reported by the client, nevertheless the exact cause of the reported event could not be conclusively determined during the analysis as handling factor could be related to the observed damage, as no manufacturing issues or anomalies could be denoted during this evaluation.Neither the phr review, nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a preface® guiding sheath with multipurpose curve for which biosense webster¿s product analysis lab (pal) identified a superficial damage in the shaft at the end of the vessel dilator.Initially it was reported that they were unable to advance the transseptal needle through the dilator of the preface® guiding sheath with multipurpose curve.The dilator was replaced with one from a new preface sheath and the issue resolved.The procedure continued.No patient consequence reported.The dilator of the preface® guiding sheath with multipurpose curve is available or return.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 14-may-2024 there was a superficial damage in the shaft at the end of the vessel dilator.The event was originally considered non-reportable, however, bwi became aware of a superficial damage in the shaft at the end of the vessel dilator on 14-may-2024 and have assessed this returned condition as reportable.

• Brand Name: PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19506975
• Report Number: 2029046-2024-01893
• Device Sequence Number: 15316462
• Product Code: DYB
• UDI-Device Identifier: 10846835000030
• UDI-Public: 10846835000030
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K982740
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 301803MS
• Device Lot Number: 18153589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK TRANSSEPTAL NEEDLE.
• Patient Sex: Unknown