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

Catalog Number	301805M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a preface® guiding sheath with multipurpose curve and the cap came off issue occurred.The cap came off the preface® guiding sheath with multipurpose curve during the procedure.They replaced the preface® guiding sheath with multipurpose curve and the procedure continued without further issues.The ngen generator was used for ablation.No patient consequence was reported.Additional information was received.The sheath was being used on a patient.There was no air that entered the patient and/or blood loss from the sheath hub.There was no patient consequence or treatment necessary.
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 24-apr-2024.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a preface® guiding sheath with multipurpose curve and the cap came off issue occurred.The device evaluation was completed on 27-jun-2024.The product was returned to biosense webster for evaluation.It was sent to device manufacturer for further investigation.Visual and dimensional analysis of the returned device were performed following bwi procedures.Visual inspection of the device revealed a kink in the sheath, with no other anomalies observed.Dimensional analysis was performed, and the device was found to be within specifications.A device history record evaluation was performed and no internal actions related to the complaint were found during the review.The brim cap issue reported by the customer was not confirmed.However, a kink was detected in the sheath.The potential cause of the kink could be related to the manipulation of the device during the procedure, however, this cannot be conclusively determined.The issue is unrelated to the reported event.The product analysis does not suggest that the reported failure 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.Explanation of codes: -investigation findings: no device problem found (c19)/ investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿cap came off " issue.-investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: rod/shaft (g04112) were selected as related to the biosense webster inc.Analysis finding of the ¿kink in the sheath¿.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• 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: 19105278
• Report Number: 2029046-2024-01225
• Device Sequence Number: 15374077
• Product Code: DYB
• UDI-Device Identifier: 10846835000061
• UDI-Public: (01)10846835000061(11)230107(17)251231(10)18174599
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,Followup,Followup
• Report Date (Section B): 07/21/2024

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: 12/31/2025
• Device Catalogue Number: 301805M
• Device Lot Number: 18174599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 04/24/2024; 06/27/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 04/30/2024; 07/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2023
• 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_NGEN RF GENERATOR
• Patient Sex: Unknown