MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER¿ ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Catalog Number	F5ADP282RT
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a webster¿ electrophysiology catheter and there was foreign matter in the connector.It was reported that during the operation, it was found that there had been foreign matter in the connector pin holes of the device, which made it unable to connect to the cable properly.There was no issue with maneuvering or withdrawing the character.The catheter pebax was not damaged.A second device was used to complete the operation.There was no adverse event reported on patient.
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).
Additional Manufacturer Narrative
On 10-sep-2024, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrial fibrillation ablation procedure with a webster¿ electrophysiology catheter and there was foreign matter in the connector.It was reported that during the operation, it was found that there had been foreign matter in the connector pin holes of the device, which made it unable to connect to the cable properly.There was no issue with maneuvering or withdrawing the character.The catheter pebax was not damaged.A second device was used to complete the operation.There was no adverse event reported on patient.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection, and microscopic examination of the returned device was following j&j procedures.Visual analysis revealed a damage on the connector, there was a piece of metal was found inside of the connector socket.No foreign material was identified during the visual analysis.Due to this condition a microscopic examination was performed and it was identified a stucked pin inside the socket.The damage could be related to the interaction of the catheter with the cable when both devices are connected; however, this can not be conclusively determined.The foreign material issue reported by the customer was not confirmed; however the connector issue was confirmed.The potential cause of the issue cannot be established.The instructions for use contain (ifu) the following direction for use: connect the catheter to the carto¿ 3 system using a compatible interface cable.Consult your local biosense webster representative for the appropriate interface cable.Connect the piu to the compatible rf generator and to the appropriate recording and mapping systems with the appropriate interface cables.Use only biosense webster interface cables.To complete the electrical circuit, connect an indifferent electrode to the indifferent electrode input on the generator.A manufacturing record evaluation was performed for the finished device number lot 31240897m and no internal action related to the complaint were found during the review.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through j&j'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).

• Brand Name: WEBSTER¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• 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: 20160994
• Report Number: 2029046-2024-02989
• Device Sequence Number: 12590857
• Product Code: LDF
• UDI-Device Identifier: 10846835000467
• UDI-Public: (01)10846835000467(17)270123(10)31240897M
• 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
• Report Date (Section B): 10/03/2024

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: F5ADP282RT
• Device Lot Number: 31240897M
• 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: 08/11/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• 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: ABBOTT APT INTRODUCER SET 6F-11CM98060112.
• Patient Sex: Unknown