MAUDE Adverse Event Report: BIOSENSE WEBSTER INC AVAIL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	F6QRD010RT
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(b)(4).
Event or Problem Description
It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with an avail¿ electrophysiology catheter and the shaft material was broken.It was reported that during the operation, the appearance of the fixed bend is damaged.The second catheter was used to complete the operation.The physician didn¿t use it in patient and switched another new one to complete the operation.There was no report on adverse event on patient.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
On (b)(6) 2024, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with an avail¿ electrophysiology catheter and the shaft material was broken.It was reported that during the operation, the appearance of the fixed bend is damaged.The second catheter was used to complete the operation.The physician didn¿t use it in patient and switched another new one to complete the operation.There was no report on adverse event on patient.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual analysis of the returned sample revealed a broken superficial mark in the shaft area with no wires exposed.No other damage or anomalies were detected during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The damage observed in the shaft could be related to the catheter broken issue reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the broken mark could not be determined, it could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.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 ref.# (b)(4).

• Brand Name: AVAIL¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 19096769
• Report Number: 2029046-2024-01210
• Device Sequence Number: 7607403
• Product Code: DRF
• UDI-Device Identifier: 10846835000528
• UDI-Public: 10846835000528
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K892265
• 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): 04/12/2024

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: 07/31/2026
• Device Catalogue Number: F6QRD010RT
• Device Lot Number: 31120516L
• 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: 03/19/2024
• Supplement Date Received by Manufacturer: 04/25/2024; 05/02/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 04/29/2024; 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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