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

Model Number	BNI35DDH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	04/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device investigation details: additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30466221l number, and no internal actions related to the complaint was found during the review.(b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old male patient ((b)(6) kg) underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® sf nav bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure, no bwi product malfunctions were reported.There was no evidence of steam pop during the ablation.No impedance nor temperature issues occurred; however, the patient complained about pain.The procedure was completed.After the procedure, the patient returned to the ward and experienced cardiac tamponade.Pericardiocentesis was done to drain the fluid.Patient¿s condition improved.There¿s no report of prolonged hospitalization.Physician¿s opinion regarding the cause of the event is that it was procedure related and that it could have occurred during the ablation.

• 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: 11749311
• Report Number: 2029046-2021-00685
• Device Sequence Number: 11086853
• Product Code: LPB
• UDI-Device Identifier: 10846835003192
• UDI-Public: 10846835003192
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2021

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: 11/22/2023
• Device Model Number: BNI35DDH
• Device Catalogue Number: BNI35DDH
• Device Lot Number: 30466221L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 04/29/2021
• 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: PENTARAY NAV ECO 7FR, D, 2-6-2
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 80