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

Catalog Number	301803M
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
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 an atrial fibrillation ablation procedure with a preface® guiding sheath with multipurpose curve and after the right atrial (ra) cavotricuspid isthmus (cti) ablation, the hemostatic valve was damaged when the qdot catheter was removed, and reverse blood was observed.Blood return only amounted to 'a few drops'.The issue was noted 4 hours after the start of the sheath use, after cti ablation.The issue was resolved by replacing the preface sheath.The hemostatic valve itself was not broken.No patient consequences were reported.
Additional Manufacturer Narrative
On 12-sep-2024, the bwi product analysis lab received the device for evaluation.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
On 6-nov-2024, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation ablation procedure with a preface® guiding sheath with multipurpose curve and after the right atrial (ra) cavotricuspid isthmus (cti) ablation, the hemostatic valve was damaged when the qdot catheter was removed, and reverse blood was observed.Blood return only amounted to 'a few drops'.The issue was noted 4 hours after the start of the sheath use, after cti ablation.The issue was resolved by replacing the preface sheath.The hemostatic valve itself was not broken.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 and dimensional and microscopical analyses of the returned device were performed following johnson & johnson medtech procedures.Visual inspection of the device revealed the brim cap detached.This component was not returned for analysis.No other anomalies were observed.Dimensional inspection was performed, this resulted within specifications.A microscopical inspection did not revealed damages on the hub area.Dhr review: a device history record evaluation was performed for the finished device number 18277327, and no internal actions related to the complaint were found during the review.The hemostatic valve issue reported by the customer was confirmed as brim cap detachment was detected during analysis.The potential cause of the brim cap detached cannot be determined.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: 20182829
• Report Number: 2029046-2024-03013
• Device Sequence Number: 8261465
• Product Code: DYB
• UDI-Device Identifier: 10846835000047
• UDI-Public: (01)10846835000047(17)261231(10)18277327
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2024

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: 18277327
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 09/12/2024; 11/06/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/04/2024; 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NRG RF TRANSSEPTAL NEEDLE 71CM (BOSTON SCIENTIFIC)
• Patient Sex: Unknown