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

Model Number	F6ADP282RT
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an supraventricular tachycardia (svt) ablation procedure with a webster¿ electrophysiology catheter and the biosense webster, inc product analysis lab observed electrodes crushed and no residues of pu (polyurethane) on the edge.Initially it was reported that before the procedure, after unpacking the package, it was found that the fifth and the sixth electrode had been thinner than other normal electrodes (provided a photo).A second device was used to complete the procedure.There was no patient consequence reported.Additional information was received.There was no physical damage to the outer box or packaging.The device was secured properly in the tray.There was no damage to the device due to any part of the packaging being damaged.All packaging will be shipped.Catheter was not pre-shaped and was not used in the patient.The issue did not result in exposure of any internal components or any lifted or sharp edges.The event was assessed as not mdr reportable for an electrode damaged without foreign material without sharp or rough edges.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 18-jan-2023, electrodes five and six were found crushed and no residues of pu (polyurethane) on the edge were observed.The electrodes founded crushed and no residues of pu (polyurethane) on the edge was assessed as mdr reportable.The awareness date for this reportable lab finding was 18-jan-2023.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 10-jan-2023.The investigation was completed on 18-jan-2023.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the electrodes 5-6 were observed with a squashed condition, no sharp edges were noted.The squashed condition noted on the electrodes are related to the customer complaint.The customer complaint was confirmed based on the picture received.The product analysis was performed as appropriate in order to find the root cause of the complaint.The product was returned to biosense webster (bwi) for evaluation.A visual inspection of the returned device was performed following bwi procedures.Visual analysis of the returned device revealed that the electrodes five and six were found crushed, and no residues of pu (polyurethane) on the edge were observed.The issue reported by the customer was confirmed.The instructions for use (ifu) contain the following recommendations: do not use excessive force to advance or withdraw the catheter through the guiding sheath when resistance is encountered.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.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.Explanation of codes: investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) were selected as related to the picture provided.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the customer reported ¿electrode damage¿.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: 16376595
• Report Number: 2029046-2023-00301
• Device Sequence Number: 6279092
• Product Code: DRF
• UDI-Device Identifier: 10846835007534
• UDI-Public: 10846835007534
• 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
• Report Date (Section B): 02/14/2023

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: 07/30/2024
• Device Model Number: F6ADP282RT
• Device Catalogue Number: F6ADP282RT
• Device Lot Number: 30618016M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2021
• 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: UNKNOWN BRAND CATHETER
• Patient Sex: Unknown