MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D-1317-07-S
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	06/07/2017
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) for the lot number 17502295l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Concomitant products: soundstar eco catheter, model #: m-5723-17, lot #: e8059193.(b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for premature ventricular contractions (pvcs) arising from the right ventricular outflow tract (rvot) with an ez steer thermocool sf nav catheter and suffered a cardiac tamponade requiring pericardiocentesis.After fast anatomical map (fam) geometry of the rvot was created, the septal side of the rvot was ablated repeatedly using 30-35 watts.Aortic cusp geometry was created via soundstar eco catheter and ablation was performed using 20-30 watts.Septal side of the rvot was ablated again using 30-35 watts.At the end of the procedure, a tamponade was confirmed via soundstar eco catheter.Pericardiocentesis yielded 500 ml.Post-procedure, the patient was transferred to the intensive care unit (icu).There is no information regarding extended hospitalization.Patient outcome is improved.It was noted that during the procedure, there were no significant changes in blood pressure, heart rate, or impedance.It was noted that the adverse event may have occurred during mapping or ablation phase.Physician indicated that there were an excessive number of ablations.There were no additional factors cited that may have contributed to the adverse event.Physician¿s opinion regarding the cause of the adverse event is that it was related to procedure or patient condition.No transseptal puncture was performed.There is no sheath information.Generator was set on power control mode.There is no information regarding generator settings at the time of injury, 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.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: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• MDR Report Key: 6673788
• Report Number: 9673241-2017-00531
• Device Sequence Number: 18846414
• Product Code: LPB
• UDI-Device Identifier: 10846835003154
• UDI-Public: (01)10846835003154(11)160623(17)190531(10)17502295L
• 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): 06/08/2017

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: 05/31/2019
• Device Model Number: D-1317-07-S
• Device Catalogue Number: BNI35BDH
• Device Lot Number: 17502295L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 06/28/2017
• 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