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	03/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).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.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 the patient underwent an ablation procedure involving a preface® guiding sheath with multipurpose curve in which the hemostatic valve was damaged during preparation before use and did not fill normal saline.The valve was not dislodged inside the hub.The brim cap and hub were not dislodged either.The sheath was replaced.The procedure was completed without patient's consequence.Hemostatic valve separation is mdr-reportable.
Additional Manufacturer Narrative
On 6-apr-2023, bwi received additional information regarding the event.There was a regurgitation from the valve when physician filled it with normal saline and that the hemostatic valve may have loosened.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 25-may-2023, the product investigation was completed.It was reported that the patient underwent an ablation procedure involving a preface® guiding sheath with multipurpose curve in which the hemostatic valve was damaged during preparation before use and did not fill normal saline.The valve was not dislodged inside the hub.The brim cap and hub were not dislodged either.The sheath was replaced.The procedure was completed without patient's consequence.Device evaluation details: the product was returned to biosense webster for evaluation.And it was sent to cordis for further investigation.During visual inspection, the brim cap/hub/hemostasis valve were thoroughly inspected and no anomalies on the assembly of the components were noted.No other anomalies were noted along the unit.A flushing test was intended, water passed from the side port tubing to the hub and came out of the tip of the sheath.No leakage was observed on the valve or the hub.A device history record evaluation was performed for finished device number (b)(6), and no internal action related to the complaint was found during the review.The complaint reported by the customer was not confirmed since no anomalies on the assembly of the valve/hub were noted.A functional test was performed to verify the functionality of the valve/hub and no leaks after the tests were noted.The exact cause of the reported event could not be conclusively determined.Procedural and/or handling factors may have contributed to the event reported.The product evaluation results do not suggest that the failure reported is related to the manufacturing process.Biosense webster¿s quality process ensures 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 ; 3035526892
• MDR Report Key: 16659442
• Report Number: 2029046-2023-00698
• Device Sequence Number: 20623252
• 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): 06/08/2023

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: 07/31/2025
• Device Model Number: 301803MS
• Device Catalogue Number: 301803MS
• Device Lot Number: 18142252
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 04/06/2023; 05/25/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 05/01/2023; 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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