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 Codes	Signal Artifact/Noise (1036); No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi 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.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 a ventricular tachycardia (vt) procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and there was no signal available for the physician to monitor the patient¿s heart rhythm.Initially it was reported that there was bad/partial signal interference (noise/loss) observed on both intracardiac and body surface channels.A second catheter was used to complete the procedure.There was no patient consequence reported.Attempts were made to obtain clarification to this complaint.However, with the information available, this signal issue was assessed as not mdr reportable as the risk to the patient was low for partial signal interference (noise/loss).Additional information was received on 9/22/2020 as it was clarified that the signal interference (noise/loss) was observed on intracardiac channels.The signal interference was seen on the carto 3 system only since no other equipment was used to monitor the patient¿s heart rhythm.There was no signal available for the physician to monitor the patient¿s heart rhythm.During the interference, the catheter was inside the patient¿s body.Since it was clarified that there was no signal available for the physician to monitor the patient¿s heart rhythm, this issue is reassessed to an mdr reportable malfunction.The awareness date for this issue is 9/22/2020.
Additional Manufacturer Narrative
The device evaluation summary was completed on (b)(6) 2020.It was reported that a patient underwent a ventricular tachycardia (vt) procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter.There was bad/partial signal interference (noise/loss) observed on both intracardiac and body surface channels.A second catheter was used to complete the procedure.There was no patient consequence reported.Additional information was received on 9/22/2020 as it was clarified that the signal interference (noise/loss) was observed on intracardiac channels.The signal interference was seen on the carto 3 system only since no other equipment was used to monitor the patient¿s heart rhythm.There was no signal available for the physician to monitor the patient¿s heart rhythm.During the interference, the catheter was inside the patient¿s body.The device was visually inspected, and it was found in good conditions.Then, electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.A manufacturing record evaluation was performed for the finished device, and no internal action related to the reported complaint condition were identified.The customer complaint cannot be confirmed.The catheter passed specification.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 10702685
• Report Number: 2029046-2020-01506
• Device Sequence Number: 14360093
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2020

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: 02/11/2023
• Device Model Number: NI75TCBH
• Device Catalogue Number: NI75TCBH
• Device Lot Number: 30347175M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 12/08/2020
• 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: CARTO 3 SYSTEM; UNKNOWN BRAND CATHETER