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

Catalog Number	BDI35DFRT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	02/20/2019
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.On 3/1/2019, a manufacturing record evaluation was performed for the finished device and no non-conformances was found during the review.Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a male patient underwent an ablation procedure with an thermocool® sf bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure when ablating at the roof line, cardiac tamponade was confirmed.Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardium.The patient was reported to be in stable condition after pericardial drainage.It is unknown if extended hospitalization was required.Patient¿s outcome was improved.The physician¿s opinion regarding the cause of the adverse event is that it was patient condition-related.No further information is available at the time.

• Brand Name: THERMOCOOL® SF 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: 8435753
• Report Number: 2029046-2019-02844
• Device Sequence Number: 2241745
• Product Code: LPB
• UDI-Device Identifier: 10846835002812
• UDI-Public: 10846835002812
• 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
• Report Date (Section B): 02/20/2019

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: 09/04/2021
• Device Catalogue Number: BDI35DFRT
• Device Lot Number: 30115962L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/20/2019
• 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