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

Model Number	NS7TCFL174HS
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrioventricular re-entry tachycardia (avrt) and a wolff-parkinson-white (wpw) procedure with a navistar¿ electrophysiology catheter and the catheter shaft was broken.It was reported that during the procedure, after removing catheter from patient, the physician noticed that the catheter was damaged on the shaft area (plastic was scratched/peeled off the shaft).Procedure continued with a new catheter.There was no patient consequence reported.Additional information was received on the event.The damage did not result in wires being exposed or any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The catheter was not pre-shaped.The sheath information was not known.The event describing the issue as ¿plastic was scratched/peeled off the shaft¿ was assessed as mdr reportable for catheter shaft was broken.
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on (b)(6) 2022.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.Manufacturer's reference number: pc-(b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrioventricular re-entry tachycardia (avrt) and a wolff-parkinson-white (wpw) procedure with a navistar¿ electrophysiology catheter and the catheter shaft was broken.It was reported that during the procedure, after removing catheter from patient, the physician noticed that the catheter was damaged on the shaft area (plastic was scratched/peeled off the shaft).Procedure continued with a new catheter.There was no patient consequence reported.Additional information was received on the event.The damage did not result in wires being exposed or any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The catheter was not pre-shaped.The sheath information was not known.The device evaluation was completed on 10-feb-2022.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the navistar device.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the as the device was found in good conditions.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.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¿ ELECTROPHYSIOLOGY CATHETER
• 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13180382
• Report Number: 2029046-2022-00033
• Device Sequence Number: 5346564
• Product Code: DRF
• UDI-Device Identifier: 10846835000610
• UDI-Public: 10846835000610
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2022

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: 06/29/2024
• Device Model Number: NS7TCFL174HS
• Device Catalogue Number: NS7TCFL174HS
• Device Lot Number: 30592871M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 01/11/2022; 02/10/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 01/19/2022; 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• 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.; UNKNOWN BRAND SHEATH.
• Patient Sex: Unknown