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

Catalog Number	301803M
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with a preface® guiding sheath with multipurpose curve and the sheath would not allow the physician to draw blood.When the sheath was replaced, the issue was resolved.No patient consequences were reported.
Additional Manufacturer Narrative
Per internal review on 4-oct-2024, it was discovered that the product receipt information was mistakenly omitted from the previous initial report.As a result, section d9 has been updated on this supplemental report.Additionally, the product investigation was completed on 4-oct-2024 for the received device.It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with a preface® guiding sheath with multipurpose curve and the sheath would not allow the physician to draw blood.When the sheath was replaced, the issue was resolved.No patient consequences were reported.Device evaluation details: the product was returned to johnson & johnson medtech for evaluation.It was sent to cordis for further investigation.Visual, dimensional and functional tests of the returned device were performed following johnson & johnson medtech procedures.Visual inspection of the device revealed no issues or anomalies in the device.Dimensional analysis was performed, given measures were within specifications.Functional analysis performed correctly without anomalies or resistance issues, no water leakage or obstruction on flushing test were encountered.A device history record evaluation was performed for the finished device number 18290648, and no internal actions related to the complaint were found during the review.The complaint reported by the customer was not confirmed.Procedural and/or handling factors might have contributed to the condition reported since the device did not present any obvious indication of manufacturing defect or anomaly that could contribute to the event.The product analysis does not suggest that the reported failure could be related to the manufacturing process of the unit.As part of johnson & johnson medtech 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: 20131375
• Report Number: 2029046-2024-02940
• Device Sequence Number: 7221628
• Product Code: DYB
• UDI-Device Identifier: 10846835000047
• UDI-Public: (01)10846835000047(17)270228(10)18290648
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 10/29/2024

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 Catalogue Number: 301803M
• Device Lot Number: 18290648
• 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: 08/06/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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