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

Model Number	BDI35DDRT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/02/2017
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 a right ventricular outflow tract (rvot) ablation procedure for premature ventricular contractions (pvcs) with a thermocool sf non-nav catheter and suffered a cardiac tamponade requiring pericardiocentesis.During the procedure, after mapping the left ventricle with a non-bwi basket catheter, the earliest point was ablated with a thermocool sf non-nav catheter.Basket catheter was inserted into the rvot and mapping was performed.Patient reported chest pain and became hypotensive.Rvot angiography confirmed that contrast media had leaked into the pericardial space.Pericardiocentesis was performed and yielded an unspecified amount of fluid.On post-procedure day 1, the patient was reported to be in stable condition.There is no information regarding extended hospitalization.Patient outcome has improved.It was noted that the event occurred during mapping phase and a non-bwi mapping system was used.There were no factors cited that may have contributed to the adverse event.Physician indicated that the location of injury had not been determined and that the patient reported chest pain while the non-bwi basket catheter was being withdrawn.Physician¿s opinion regarding the cause of the adverse event is that was related to procedure or patient condition.There is no information regarding transseptal puncture.There is no sheath information.Generator was set on power control mode.There is no information regarding generator settings, power titration, overall ablation time at the site of injury, last ablation cycle time at the site of injury, irrigated catheter flow setting, or anticoagulation during the procedure.There were no errors reported on any bwi equipment during the procedure.

• Brand Name: THERMOCOOL SF
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine 92618
• MDR Report Key: 6817696
• Report Number: 9673241-2017-01011
• Device Sequence Number: 13485822
• Product Code: LPB
• UDI-Device Identifier: 10846835002805
• UDI-Public: (01)10846835002805(11)170419(17)180331(10)17668125L
• Combination Product (Y/N): N
• 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): 08/02/2017

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: 03/31/2018
• Device Model Number: BDI35DDRT
• Device Catalogue Number: BDI35DDRT
• Device Lot Number: 17668125L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 08/24/2017
• 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