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

Model Number	BDI35DFRT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	ST Segment Elevation (2059); Cardiac Tamponade (2226)
Date of Event	09/04/2017
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.Concomitant products: coolflow tubing set, model # d-1233-01-s, lot # 106037.Boston scientific intellamap orion mapping catheter.(b)(4).
Event or Problem Description
It was reported that a patient underwent an idiopathic ventricular tachycardia/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) and electrocardiogram st segment elevation (with no interventions reported).Mapping was performed with a boston scientific intellamap orion mapping catheter.Ablation was performed on the rvot and the opposite side of the left ventricle (unspecified).Pvc morphology was modified by ablation.Mapping and ablation were repeated.Patient became hypotensive and the st segment became elevated.Pericardial effusion was confirmed via echocardiography.Pericardiocentesis yielded an unspecified amount of fluid.Patient recovered and was reported to be in stable condition.There is no information regarding extended hospitalization.Patient outcome is improved.There were no patient factors cited that may have contributed to the adverse event.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related.Physician indicated that it is unknown when the adverse event occurred.It was noted that a puncture may have occurred after mapping phase while removing the boston scientific intellamap orion mapping catheter from the sheath.It was also noted that no changes were observed while using the bwi product.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 parameters, generator settings, power titration, overall ablation time at the site of injury, last ablation cycle time at the site of injury, or irrigated catheter flow setting.Patient did not receive anticoagulant during the procedure.There were no errors observed 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 dr.; irvine CA 92618
• MDR Report Key: 6894275
• Report Number: 9673241-2017-01107
• Device Sequence Number: 16333985
• Product Code: LPB
• UDI-Device Identifier: 10846835002812
• UDI-Public: (01)10846835002812(11)170306(17)200229(10)17652226L
• 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): 09/04/2017

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: 02/29/2020
• Device Model Number: BDI35DFRT
• Device Catalogue Number: BDI35DFRT
• Device Lot Number: 17652226L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2017
• Initial Report FDA Received Date: 09/26/2017
• 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