MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	BNI35DFH
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a thermocool® sf nav bi-directional catheter and post-procedure the bwi product analysis lab identified a damage/separation at the tip/shaft transition with exposed components.During the mapping with ablation catheter, the physician took the catheter out of the patient.Under the electrodes, the catheter had damaged.The catheter was replaced and the procedure completed.No patient consequences were reported.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed a damage/separation at the tip/shaft transition with exposed components.During the analysis adhesive was observed on the transition area, due this condition, the issue could be related to excessive force during manipulation of the device; however, this cannot be conclusively determined.No damages on the electrodes were observed.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the manufacturing process to avoid this type of damage from leaving the facility.The issue reported by the customer was confirmed due to the damage observed at the tip/shaft transition.The condition matches the information provided by the customer regarding damage under the electrodes.A manufacturing record evaluation was performed for the finished device 31044047l number, and no internal action related to the complaint was found during the review.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 reference number: (b)(4).

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS 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 92618 ; 3035526892
• MDR Report Key: 18741717
• Report Number: 2029046-2024-00551
• Device Sequence Number: 17950453
• Product Code: LPB
• UDI-Device Identifier: 10846835003215
• UDI-Public: 10846835003215
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P030031/S025
• 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
• Report Date (Section B): 02/20/2024

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: 05/18/2026
• Device Catalogue Number: BNI35DFH
• Device Lot Number: 31044047L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2023
• 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