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

Catalog Number	BNI35DFH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for premature ventricular contractions (pvcs) with a thermocool sf nav catheter and suffered a cardiac tamponade.During mapping in the right ventricle, a perforation occurred.Patient fully recovered.Factors cited that may have contributed to the adverse event include the patient¿s condition, specifically, thin myocardial tissue.No transseptal puncture was performed.No ablation was performed.
Additional Manufacturer Narrative
Additional information was received on may 22, 2018.The patient involved was a b)(6)-year-old male with a preprocedural diagnosis of flutter.The patient did not require any additional medical intervention, surgical intervention or extended hospitalization due to the adverse event.The patient has since fully recovered.The physician¿s opinion on the causality of the adverse event is it was patient condition related, possibly due to the patient¿s anatomy.No transseptal puncture was performed.There was no ablation performed as the event occurred during the mapping phase.Irrigation flow was 2 ml/min during mapping.There were no error messages observed on biosense webster equipment during the procedure.No sheath or anticoagulant were used during the procedure.Manufacturer's ref.No: (b)(4).

• Brand Name: THERMOCOOL SF NAV CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7248519
• Report Number: 2029046-2018-01163
• Device Sequence Number: 11066616
• Product Code: LPB
• UDI-Device Identifier: 10846835003215
• UDI-Public: 10846835003215
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 01/15/2018

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: 07/31/2019
• Device Catalogue Number: BNI35DFH
• Device Lot Number: 17538841L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 05/29/2018
• 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
• Patient Age: 60 YR