MAUDE Adverse Event Report: BIOSENSE WEBSTER INC 4MM NAVIGATIONAL BI-DIRECT; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Model Number	BN7TCFJ4L
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a supraventricular tachycardia (svt) procedure with an ez steer¿ nav bi-directional electrophysiology catheter and an internal components exposed issue occurred.It was reported by the biosense webster inc.(bwi) representative that during a procedure, the physician noticed that the catheter was not bending properly and when the physician looked on flouro, he could see that the tip was bent and had a kink in it.To troubleshoot, the catheter was replaced, the issue was resolved, and the procedure was continued.No adverse patient consequence was reported.The damage resulted in wires being exposed.The damage did not result in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The issue was found between the distal and proximal electrodes.The bent tip issue is not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The internal components exposed issue is mdr reportable.
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).
Additional Manufacturer Narrative
It was reported that a patient underwent a supraventricular tachycardia (svt) procedure with an ez steer¿ nav bi-directional electrophysiology catheter and an internal components exposed issue occurred.It was reported by the biosense webster inc.(bwi) representative that during a procedure, the physician noticed that the catheter was not bending properly and when the physician looked on flouro, he could see that the tip was bent and had a kink in it.To troubleshoot, the catheter was replaced, the issue was resolved, and the procedure was continued.No adverse patient consequence was reported.The damage resulted in wires being exposed.The damage did not result in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The issue was found between the distal and proximal electrodes.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, deflection, and tilt test of the returned device were performed following bwi procedures.Visual analysis revealed that the tip was found bent, no other damage was observed.The customer includes in an additional note that the damage resulted in wires exposed, however, during a detailed examination under the microscope, no wires exposed were observed.A deflection test was performed, and the curve was deflecting within specifications.The tip was observed bent, because of this, a tilt test was performed, and the tip was outside the specification.The tip deviation could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device number lot 31039589m and no internal actions related to the complaint were found during the review.The issue reported by the customer 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.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the tip that was observed bent.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the wires being exposed as reported by the customer.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: 4MM NAVIGATIONAL BI-DIRECT
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• 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: 17218621
• Report Number: 2029046-2023-01405
• Device Sequence Number: 15008625
• Product Code: LPB
• UDI-Device Identifier: 10846835003031
• UDI-Public: 10846835003031
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P990025/S12
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2023

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: 04/24/2026
• Device Model Number: BN7TCFJ4L
• Device Catalogue Number: BN7TCFJ4L
• Device Lot Number: 31039589M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 4MM NAVIGATIONAL BI-DIRECT
• Patient Sex: Unknown