MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	NI75TCJH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	04/05/2018
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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Concomitant bwi products include: thermocool® smart touch® sf uni-directional navigation catheter (us catalog # d134703, lot # unknown); lasso catheter (us catalog # unknown, lot # unknown); carto 3 system (us catalog # unknown, serial # unknown).Concomitant non-bwi products include: baylis medical transseptal needle.(b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient underwent an ablation procedure for symptomatic paroxysmal atrial fibrillation with a navi-star¿ thermo-cool¿ electrophysiology catheter and suffered a cardiac tamponade requiring pericardiocentesis.Four hours post-procedure, while in the recovery room, a pericardial effusion was confirmed via echocardiography.Pericardiocentesis yielded an unspecified volume of fluid.There is no information regarding the patient¿s condition.Patient required extended hospitalization as a result of the adverse event.There is no information regarding the patient¿s outcome.Factors cited that may have contributed to the adverse event include patient¿s age and extensive left atrial appendage (laa) ablation.Physician¿s opinion regarding the cause of the adverse event is that it was related to the procedure and the patient¿s condition.It was noted that the injury most likely occurred during ablation phase.There were no issues or errors reported on any bwi products or equipment during the procedure.Transseptal puncture was performed with a baylis medical transseptal needle.There is no sheath information.Generator was set on power control mode at 40-47 watts.Generator parameters and settings at the time of injury were not reported, as the time of injury is unknown.Power was not titrated during ablation.Overall ablation time and last ablation cycle time at the site of injury were not reported, as the site of injury is unknown.Irrigated catheter flow was set on 17 ml/min for the thermocool® smart touch® sf uni-directional navigation catheter and 30 ml/min for the navi-star¿ thermo-cool¿ electrophysiology catheter.Patient received anticoagulant during the procedure with activated clotting time (act) maintained at greater than 300 seconds.There is no information regarding spi value.Thermocool® smart touch® sf uni-directional navigation catheter was in close proximity to the lasso catheter.Thermocool® smart touch® sf uni-directional navigation catheter was zeroed after the initial warm-up phase post catheter connection to the carto 3 patient interface unit.Carto 3 system did not indicate to re-zero the catheter.There were no issues or errors reported on any bwi products or equipment during the procedure.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

• Brand Name: NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 7478382
• Report Number: 2029046-2018-01499
• Device Sequence Number: 1768799
• Product Code: OAD
• UDI-Device Identifier: 10846835000573
• UDI-Public: 10846835000573
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• 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): 04/05/2018

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: NI75TCJH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 05/01/2018
• 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: Hospitalization; Life Threatening; Required Intervention