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

Model Number	301803MS
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a preface® guiding sheath with multipurpose curve.There was a valve physical abnormality.There was a hemostasis valve failure, valve physical abnormality.Reverse blood was present at the time of the septal puncture into the left atrium.This occurred 1 hour and 30 minutes after insertion of the sheath, at the time of the septal puncture in the left atrium.The catheter was exchanged to resolve the event, and the procedure was continued.The sheath was not being used on the patient.The complaint product was replaced to another sheath.Blood return was observed.No patient consequences were reported.Hemostatic valve separation is mdr-reportable.
Additional Manufacturer Narrative
On 5-sep-2022, bwi received information indicating that the sheath was inserted into the patient when the complaint issue happened.On 8-sep-2022, 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 5-oct-2022, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a preface® guiding sheath with multipurpose curve.There was a valve physical abnormality.Device evaluation details: visual analysis of the returned sample revealed no anomalies in the components returned.The functional and microscopic analyses were found within specifications.A manufacturing record evaluation was performed for finished device number 18079353, and no internal action related to the complaint was found during the review.The complaint reported by the customer as ¿hemostasis valve/hub ¿ leakage - during use¿ was not confirmed since during functional test no leaks were noted on the valve/hub.The exact cause of the reported event could not be conclusively determined during the analysis.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15317748
• Report Number: 2029046-2022-02039
• Device Sequence Number: 20141258
• Product Code: DYB
• UDI-Device Identifier: 10846835000030
• UDI-Public: 10846835000030
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2022

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: 12/31/2024
• Device Model Number: 301803MS
• Device Catalogue Number: 301803MS
• Device Lot Number: 18079353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 09/05/2022; 10/05/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 09/19/2022; 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2022
• 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