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

Catalog Number	D131503
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	09/23/2019
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.A manufacturing record evaluation was performed for the finished device and no internal actions were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.
Event or Problem Description
It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure for with a thermocool® sf nav uni-directional catheter and suffered cardiac tamponade.During mapping phase in the right ventricle with the thermocool® sf nav uni-directional catheter, pericardial effusion was noticed.The patient's blood pressure dropped, and pericardial effusion was confirmed by echocardiogram and x-ray.Pericardiocentesis was performed to remove 300cc of fluid.Extended hospitalization was required for monitoring following pericardiocentesis.Thereafter, patient was reported to be in stable condition.No ablations were delivered.No transseptal was performed and no steam pop was reported.Patient had fully recovered.The patient's condition was resolved.Physician¿s opinion on the cause of this adverse event was both the procedure and patient condition.Irrigated catheter flow settings were set at 2 ml/min.No error messages observed on biosense webster equipment during the procedure.No error messages on any biosense webster inc.(bwi) equipment was 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: 9205752
• Report Number: 2029046-2019-03774
• Device Sequence Number: 16881636
• Product Code: LPB
• UDI-Device Identifier: 10846835009293
• UDI-Public: 10846835009293
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2019

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 Expiration Date: 06/03/2022
• Device Catalogue Number: D131503
• Device Lot Number: 30231952L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/17/2019
• 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
• Patient Age: 72 YR