MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	NI75TCBH
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and a deflection stuck issue occurred.Initially it was reported that there was a deflection issue.During the procedure, the navi-star¿ thermo-cool¿ electrophysiology catheter was unable to deflect or relax completely.A second catheter was used to complete the procedure.There was no patient consequence reported.The event was assessed as not mdr reportable for a deflection issue.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.Additional information was received on 07-feb-2022.The curve of the catheter was stuck jammed in a full deflected position.The knob/piston was able to be turned and pushed up and down.There was no difficulty in removing the catheter.The additional information stating that the catheter was stuck jammed in a full deflected position was assessed as an mdr reportable deflection stuck issue.Therefore, the awareness date for this reportable issue is 07-feb-2022.
Additional Manufacturer Narrative
The biosense webster inc.Product analysis lab received the device for evaluation on 19-feb-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: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and a deflection stuck issue occurred.Initially it was reported that there was a deflection issue.During the procedure, the navi-star¿ thermo-cool¿ electrophysiology catheter was unable to deflect or relax completely.A second catheter was used to complete the procedure.There was no patient consequence reported.Additional information was received on the event.The curve of the catheter was stuck jammed in a full deflected position.The knob/piston was able to be turned and pushed up and down.There was no difficulty in removing the catheter.The investigation was completed on 13-apr-2022.An analysis was performed on the pictures that were provided by the customer.Pictures showing the catheter semi-deflected were received for analysis.The photos do not provide sufficient information related to the reported event and therefore, no result can be obtained from them.The customer complaint cannot be confirmed.The product analysis was performed as appropriate in order to find the root cause of the complaint.The device was returned to biosense webster for evaluation.Visual inspection and deflection test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.The deflection issue 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.A manufacturing record evaluation was performed for the finished device 30594564m number, and no internal actions related to the complaint were found during the review.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.H6.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video 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: NAVI-STAR¿ THERMO-COOL¿ 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13657399
• Report Number: 2029046-2022-00435
• Device Sequence Number: 12014207
• Product Code: OAD
• UDI-Device Identifier: 10846835008333
• UDI-Public: 10846835008333
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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: 06/23/2024
• Device Model Number: NI75TCBH
• Device Catalogue Number: NI75TCBH
• Device Lot Number: 30594564M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BRAND CATHETER
• Patient Sex: Unknown