MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	BN7TCFJ8L
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biosense webster, inc.Product analysis lab received the device for evaluation.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.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).
Event or Problem Description
It was reported that a patient underwent an atrial flutter right (r-afl) ablation procedure with a ez steer¿ nav ds bi-directional electrophysiology catheter and an electrode damaged issue occurred.It was reported by the biosense webster inc.(bwi) representative that the physician felt the contact force of the ablation catheter did not feel right.The ablation catheter was removed from the patient and inspected.Upon inspection, they saw a dent on the distal electrode close to the tip of the ablation catheter.The damage did not result in wires being exposed.There was difficulty in the removal of the catheter.The catheter was not pre-shaped.The physician stated that the catheter felt different physically while in the body.He just stated that it felt differently when he saw that it was in contact with the tissue on fluoroscopy.They exchanged the ablation catheter, and the issue was resolved, and the case continued.No adverse patient consequence was reported.The electrode damaged issue was assessed as mdr reportable.
Additional Manufacturer Narrative
The device evaluation was completed on 13-jan-2023.It was reported that a patient underwent an atrial flutter right (r-afl) ablation procedure with a ez steer¿ nav ds bi-directional electrophysiology catheter and an electrode damaged issue occurred.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed that the tip was bent with no internal components exposed nor lifted; however, the electrodes were found in good condition.The complaint was confirmed since the bent tip condition could be related to the damage reported by the customer; other issues or circumstances may have occurred during the usage of the device that compromised its performance.A manufacturing record evaluation was performed for the finished device 30870550m number, and no internal actions related to the reported complaint condition were identified.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: EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 16110414
• Report Number: 2029046-2023-00032
• Device Sequence Number: 6838997
• Product Code: OAD
• UDI-Device Identifier: 10846835003048
• UDI-Public: 10846835003048
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010068/S6
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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: 09/07/2025
• Device Model Number: BN7TCFJ8L
• Device Catalogue Number: BN7TCFJ8L
• Device Lot Number: 30870550M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• 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: 8MM NAVIGATIONAL BI-DIRECT.
• Patient Sex: Unknown