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

Catalog Number	301803MS
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a preface® guiding sheath with multipurpose curve and there was problem with connector of the device or cable.The medical team confirmed that the components at the end of the device (hemostatic valve) fell off.A second device was used to complete the operation.There was no adverse event reported on patient.
Additional Manufacturer Narrative
The product investigation was completed.Device evaluation details: the product was returned to biosense webster for evaluation.It was sent to cordis for further investigation.Visual dimensional and microscopic analyses of the returned device were performed following bwi procedures.Visual inspection of the device revealed that the cap was separated from the hub.The cap was not returned for analysis.The brim cap could be related to the issue reported by the customer.Dimensional and microscopic analysis was performed and no issues were detected.  a device history record evaluation was performed for the finished device number 18166192,  and no internal actions related to the complaint were found during the review.The complaint reported by the customer was confirmed, the returned unit present a cap separation was observed.The potential cause of the damage could be related to the handling, however, this cannot be conclusively determined.Procedural factors or handling process may contribute to this issue.Controls are in place to verify the product conditions; the cap assembly are inspected 100% before leaving the facility.Neither the phr review nor the product analysis suggests that the found damage 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.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: 19148091
• Report Number: 2029046-2024-01309
• Device Sequence Number: 7443839
• Product Code: DYB
• UDI-Device Identifier: 10846835000030
• UDI-Public: 10846835000030
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2024

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: 10/31/2025
• Device Catalogue Number: 301803MS
• Device Lot Number: 18166192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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
• Patient Sex: Unknown