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

Catalog Number	D131803
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Pericardial Effusion (3271)
Date of Event	09/27/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.We are working on the manufacture record evaluation (mre), once we get more information it will be submitted in the supplemental.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old patient underwent an ablation procedure for ventricular tachycardia (vt) procedure with a thermocool® sf nav uni-directional catheter and suffered cardiac tamponade and death.Transseptal puncture was performed with a st.Jude medical brk needle.Ablation was performed before the effusion was discovered.Pericardiocentesis was performed.Patient suffered outcome of death later that evening.The physician¿s opinion is that the outcome is related to the patient condition and procedure.No steam pop was reported.No error messages on and biosense webster inc.(bwi) equipment were reported.

• Brand Name: THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9236743
• Report Number: 2029046-2019-03813
• Device Sequence Number: 16628013
• Product Code: LPB
• UDI-Device Identifier: 10846835009279
• UDI-Public: 10846835009279
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030031/S034
• 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
• Report Date (Section B): 09/27/2019

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 Catalogue Number: D131803
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/25/2019
• 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: ST. JUDE MEDICAL BRK NEEDLE
• Outcome Attributed to Adverse Event: Death; Required Intervention