MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	D135304
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a persistent atrial fibrillation procedure with a webster cs catheter with auto id technology and a deflection issue occurred which made the removal from the patient difficult.The catheter did not respond well to deflection and the movements created were not those desired.The device was very "soft" as soon as it was introduced into the femoral desilet and rolled up on itself making its use impossible and its removal from the patient difficult (refusing to unroll the doctor risked damaging the femoral vein).The doctor managed to remove the device without damaging the vein and used another device to continue the procedure.The surgery was not delayed due to the reported event.The procedure was successfully completed.There was no patient consequence reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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).
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 28-nov-2023.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
It was reported that a patient underwent a persistent atrial fibrillation procedure with a webster cs catheter with auto id technology.The catheter did not respond well to deflection and the movements created were not those desired.The device was very "soft" as soon as it was introduced into the femoral desilet and rolled up on itself making its use impossible and its removal from the patient difficult (refusing to unroll the doctor risked damaging the femoral vein).The doctor managed to remove the device without damaging the vein and used another device to continue the procedure.The investigation was completed on 07-dec-2023.The device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation and deflection test of the returned device was performed following bwi procedures.Visual analysis of the returned sample revealed bent marks along the shaft.A deflection test was performed and the curve was found stuck in a deflected position.Further investigation revealed that the damages along the shaft could be related to the deflection issue; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.Since several stress marks were found along the shaft, this failure could be related to the issue reported by the customer; therefore the customer complaint was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi¿s quality system.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
Udi related data quality updates only.Correction to the initial mdr, incomplete udi was provided.Section d4.Primary udi number has been updated with full udi (b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY
• 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: 18116929
• Report Number: 2029046-2023-02611
• Device Sequence Number: 20735357
• Product Code: DRF
• UDI-Device Identifier: 10846835009989
• UDI-Public: (01)10846835009989(11)230904(17)260903(10)31126453M
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K080425
• 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,Followup
• Report Date (Section B): 01/01/2024

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: 09/03/2026
• Device Catalogue Number: D135304
• Device Lot Number: 31126453M
• 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: 10/19/2023
• Supplement Date Received by Manufacturer: 11/28/2023; 12/07/2023; 07/09/2024
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 12/04/2023; 01/01/2024; 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2023
• 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