MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) 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 06/07/2017

Event Type  Injury  

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.Since the lot number is unknown, the full udi number can not be provided.(b)(4).

Event Description

It was reported that a patient underwent a atrial flutter left (l-afl) procedure with a navistar rmt thermocool catheter and suffered a cardiac tamponade which required a pericardiocentesis.During the procedure, a cardiac tamponade was noticed as the patient's blood pressure dropped.The cardiac tamponade was confirmed by an intracardiac echocardiography.They performed a pericardiocentesis and an unknown amount of fluid was removed.The patient was reported to be in the operating room.No further information is known regarding the patient status.There is no information about the hospitalization.The physician did not provide a causality opinion for the cause of this adverse event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.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.

Manufacturer Narrative

Additional information was received on july 11, 2017 on the event.The patient was male.The procedure originally reported was an atrial flutter left.However, the additional information provided stated it was a persistent atrial fibrillation.During the ablation phase, the patient became hypotensive.The pericardiocentesis yielded an unspecified amount of fluid.Patient was reported to be in the operating room (or) for surgical drainage.Patient required extended hospitalization as a result of the adverse event.Patient fully recovered with no residual effects.Patient was noted to be in atrial fibrillation during the procedure.There were no 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 stereotaxis.A transseptal puncture was performed with an unspecified needle.There is no sheath information.Generator was set on temperature control mode with impedance of 190 ohms.There is no information regarding other generator settings or power titration.Overall ablation time at the site of injury was 1 min and 37 seconds.Last ablation cycle time at the site of injury was 1 minute and 37 seconds.Irrigated catheter flow was set at 2 ml/min while on low flow.There is no information regarding anticoagulation during the procedure.There were no errors reported on any bwi equipment during the procedure.(b)(4).

• 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. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6673785
• MDR Text Key: 78610762
• Report Number: 2029046-2017-00213
• Device Sequence Number: 1
• Product Code: OAD
• 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,Followup
• Report Date: 06/07/2017

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 Model Number: D-1266-01-S
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: UNKNOWN_D-1266-01-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 06/28/2017
• Supplement Dates Manufacturer Received: 06/07/2017
• Supplement Dates FDA Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: No
• 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