MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR; CATHETER, ELECTRODE RECORDING

Catalog Number	NS7TCDL174HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrioventricular reentrant tachycardia/wolff-parkinson-white (avrt/wpw) ablation procedure with a navistar and when removing the ablation catheter from the body, the tip of the catheter partially separated, exposing internal wires.The issue occurred at the end of the procedure.No adverse patient consequence was reported.Additional information was received.It was noted that the damage resulted in lifted rings.There was difficulty during the removal of the catheter.
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
It was reported that a patient underwent an atrioventricular reentrant tachycardia/wolff-parkinson-white (avrt/wpw) ablation procedure with a navistar and when removing the ablation catheter from the body, the tip of the catheter partially separated, exposing internal wires.The issue occurred at the end of the procedure.No adverse patient consequence was reported.Additional information was received.It was noted that the damage resulted in lifted rings.There was difficulty during the removal of the catheter.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 that the connector was separated from the handle of the catheter.The tip was observed without issues and no wires were exposed in the tip area.A manufacturing record evaluation was performed for the finished device number lot 31259445m and no internal action related to the complaint was found during the review the broken tip reported by the customer could not be replicated during the product investigation.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.The potential cause of the detached connector could be related to the manipulation of the catheter during or after the procedure; however, this could not be conclusively determined.The instruction for use of the device contain the following recommendations: do not insert or withdraw the catheter without straightening the catheter tip (pulling the thumb knob back); do not scrub or twist the tip electrode as damage may cause catheter failure or patient injury.Use appropriate biosense webster accessory cables to connect the catheter to the carto 3 system and a compatible rf generator.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Correction to the initial report: corrected full udi has been populated to field d4.Primary udi number.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: NAVISTAR
• Common Device Name: CATHETER, ELECTRODE RECORDING
• 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: 19954331
• Report Number: 2029046-2024-02658
• Device Sequence Number: 18383227
• Product Code: DRF
• UDI-Device Identifier: 10846835000597
• UDI-Public: (01)10846835000597(17)270225(10)31259445M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990025
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: NS7TCDL174HS
• Device Lot Number: 31259445M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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: MULLENS 7FR SHEATH; STOCKERT GENERATOR
• Patient Sex: Unknown