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

Catalog Number	NI75TCFH
Medical Device Problem Code	No Pacing (3268)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A manufacturing record evaluation was performed for the finished device 30090961m number, and no internal actions related to the reported complaint condition were identified.The biosense webster inc.Product analysis lab received the device for evaluation on 5/3/2019.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.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent a procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and a pacing problem affected emergency pacing.It was initially reported that they were unable to pace.There were no patient consequences reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The pacing issue described was assessed as not reportable.The catheter would need to be replaced since it was not able to pace for stimulation.There would be no risk to the patient.Additional information was received on april 8, 2019 on the event.The pacing leads were connected to the primary pacing port.The ep4 pacing stimulator was being used during the procedure.There was no unwanted pacing being delivered.The pacing problem affected both routine and emergency pacing.There was no patient consequence reported.Based on the additional information stating that the pacing problem also affected emergency pacing, this pacing issue has been re-assessed to mdr reportable.The awareness date is april 8, 2019.
Additional Manufacturer Narrative
Investigation summary: it was reported that a patient underwent a procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and a pacing problem affected emergency pacing.It was initially reported that they were unable to pace.There were no patient consequences reported.Additional information was received on april 8, 2019 on the event.The pacing leads were connected to the primary pacing port.The ep4 pacing stimulator was being used during the procedure.There was no unwanted pacing being delivered.The pacing problem affected both routine and emergency pacing.There was no patient consequence reported.The device was visually inspected and it was found in good conditions.Then, an electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Then, an irrigation test was performed and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed.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: 8584144
• Report Number: 2029046-2019-03069
• Device Sequence Number: 16734058
• Product Code: OAD
• UDI-Device Identifier: 10846835000566
• UDI-Public: 10846835000566
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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: 07/11/2021
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 30090961M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1