MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1266-01-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 06/26/2017

Event Type  Injury  

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 17653097m has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.Concomitant products: non-biosense webster, inc.- st.Jude medical brk-1 transseptal needle.Non-biosense webster, inc.- st.Jude medical sl1 8.5 french sheath.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial tachycardia with a navistar rmt thermocool catheter and suffered a cardiac tamponade requiring pericardiocentesis.During mapping, the patient became hypotensive and a tamponade was confirmed via intracardiac echocardiogram (ice).Pericardiocentesis yielded 500 ml.Patient was reported to be in stable condition.There is no information regarding extended hospitalization.Patient outcome is improved.Factors cited that may have contributed to the adverse event include the patient¿s anatomy.Physician¿s opinion regarding the cause of the adverse event is that it was related to the patient¿s anatomy.Transseptal puncture was performed with a st.Jude medical brk-1 transseptal needle and a st.Jude medical sl1 8.5 french sheath.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 received anticoagulant during the procedure with activated clotting time maintained between 300-350 seconds.There were no errors reported on any biosense webster, inc.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: NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6730903
• MDR Text Key: 80627367
• Report Number: 9673241-2017-00586
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: (01)10846835008500(11)170321(17)200228(10)17653097M
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: D-1266-01-S
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 17653097M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2017
• Initial Date FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention