MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	BNI35DFH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30449397l number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that an (b)(6) male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® sf nav bi-directional catheter and suffered heart block requiring a temporary pacemaker.After cardioversion (dc), sinus did not appear with the thermocool sf catheter.Pulmonary vein isolation (pvi) plus line ablation was performed in long-standing persistent af (lsaf) procedure and after that, dc was performed, but sinus did not come out.The patient left the room with temporary pacing.The patient outcome of the adverse event was reported as improved.There was no report that extended hospitalization was required.The physician commented that "since it was sss at the last time sinus was confirmed," the sinus has not come out already from the time of entering the room, and it may be unrelated to the procedure.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that it was patient condition related.The physician thought that since the patient has sick sinus syndrome at the last time sinus rhythm was confirmed, the patient already has sick sinus from the time of admission, and it was not related to the procedure.

• Brand Name: THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12464078
• Report Number: 2029046-2021-01542
• Device Sequence Number: 13764493
• Product Code: LPB
• UDI-Device Identifier: 10846835003215
• UDI-Public: 10846835003215
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030031/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2023
• Device Model Number: BNI35DFH
• Device Catalogue Number: BNI35DFH
• Device Lot Number: 30449397L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR