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

Model Number	BNI35BDH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 30322200l 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.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 premature ventricular contraction (pvc) ablation procedure with a thermocool® sf nav bi-directional catheter and developed ventricular tachycardia (vt) and ventricular fibrillation (vfib) requiring external direct-current (dc) cardioversion.During ablation of the right ventricle outflow tract (rvot), the patient developed vt/vfib.External dc cardioversion was applied and returned to sinus rhythm.Treatment continued and patient¿s hemodynamics was stable upon leaving the room.There¿s no indication that extended hospitalization was required.Physician commented that the causal relationship between the adverse event and the biosense webster (bwi) product is unlikely.No biosense webster, inc.Product malfunctions nor error messages were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
During an internal review on 11/2/2020, noted a correction to the 3500a initial as it was missing the 3500a ¿method code¿ of ¿analysis of production records¿.Therefore, populated this field.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
Additional information was received on 10/4/2020.The patient¿s gender is male.The patient¿s condition had improved.Therefore, updated a 3.Sex field.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: THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10458301
• Report Number: 2029046-2020-01117
• Device Sequence Number: 14175433
• Product Code: LPB
• UDI-Device Identifier: 10846835003154
• UDI-Public: 10846835003154
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2020

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: 12/04/2022
• Device Model Number: BNI35BDH
• Device Catalogue Number: BNI35BDH
• Device Lot Number: 30322200L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 10/04/2020; 11/02/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 11/01/2020; 11/02/2020
• 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: Life Threatening; Required Intervention