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 Bradycardia (1751); Death (1802); Loss of consciousness (2418)

Event Date 11/20/2014

Event Type  Death  

Event Description

It was reported that during an idiopathic ventricular tachycardia case using a navistar rmt thermocool catheter, the patient¿s heart rate dropped after 45 seconds of ablation.The patient then became unresponsive.Cpr was performed and unknown medications were given.The resuscitation efforts were unsuccessful.The patient expired.The cause or type of the fatal injury was unknown.There were no reported malfunctions of any bwi products during the procedure.

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.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)(6).Concomitant products: carto 3 system, model #: unknown, serial #: unknown.Stockert, model #: unknown, serial #: unknown.Cool flow pump, model #: unknown, serial #: unknown.Bard catheter (non-biosense webster).Quad catheter (non-biosense webster).(b)(4).

Manufacturer Narrative

Originally the lot number reported was unknown.After receiving the catheter, the lot number has been verified as 17090551m.Therefore, the udi # is (b)(4).Manufacturer's ref.No: (b)(4).It was reported that during an idiopathic ventricular tachycardia case using a navistar rmt thermocool catheter, the patient¿s heart rate dropped after 45 seconds of ablation.The patient then became unresponsive.Cpr was performed and unknown medications were given.The resuscitation efforts were unsuccessful.The patient expired.The cause or type of the fatal injury was unknown.There were no reported malfunctions of any bwi products during the procedure.Upon receipt, the product was visually inspected and it was found a clear like material at the end of the catheter handle.This condition was not reported by the customer.Per the manufacturing process the clear material was confirmed as an excessive application of pu at the sleeve-handle section; catheter lot number was reviewed for a similar failure but there was none.A report was run in order to find complaints with the same characteristics but there was no complaints found.This is considered as an isolated manufacturing issue.Awareness training was performed to the manufacturing assembly associates in order to avoid an excessive application of pu.Per the event reported, the catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.The catheter was evaluated for eeprom, carto 3 and sensor functionality.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.A deflection test was performed and the catheter passed.Furthermore, an irrigation test was performed and the catheter passed, no occlusion was observed.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.The catheter failed during visual inspection however the root cause of the patient¿s death remains unknown.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 1/5/15.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(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: jaime chavez ; 9098398483
• MDR Report Key: 4333959
• MDR Text Key: 18292035
• Report Number: 2029046-2014-00479
• 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,Followup
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: D-1266-01-S
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: UNKNOWN_D-1266-01-S
• Other Device ID Number: (01)10846835008500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2014
• 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): Death; Required Intervention
• Patient Age: 74 YR