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 Problems Break (1069); Kinked (1339); Device Contamination with Chemical or Other Material (2944); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

This damage resulted in internal catheter components being exposed posing a critical risk to the patient due to the potential of thrombus from exposure to internal catheter components.Multiple attempts have been made to obtain clarification to these findings.However, no further information has been made available.Awareness date has been reset to june 21, 2017, the date of the reportable finding.The bwi failure analysis lab received the device for evaluation.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.Manufacturer's ref.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a navistar rmt thermocool electrophysiology catheter and a high temperature was displayed.A map of the left ventricle was created and the stockert generator showed an unusually high tip temperature of 85c.This was the temperature limiter/cutoff; therefore, ablation was not possible.During the procedure, the pump was constantly running.The catheter was removed and it was noted that there was blood in the catheter handle after it was removed from the patient.In addition, blood dripped out of the catheter.The catheter was exchanged with a new catheter and the procedure was completed successfully with no patient consequence.This event was originally assessed as not mdr reportable because if the temperature exceeds the user-selected cutoff, and the generator stopped delivering rf energy as intended, then the risk to the patient is remote.In addition, the blood is also not reportable because this came from the patient and does not pose a risk to them.On june 21, 2017, the biosense webster failure analysis lab discovered that the catheter was kinked at approximately 25.5 cm and 30.0 cm from the distal dome.In addition, the shaft-tip fusion was found open with reddish brown material inside.The broken fusion showed elongation and internal components were exposed.Furthermore, the connector receptacle and pins had a dark reddish brown material on them.The issue with reddish brown material is not mdr reportable because the presence of a reddish-brown material is an expected finding after these procedures.The kinks in the catheter are also not mdr reportable because the catheter integrity was maintained, therefore the potential that it could cause or contribute to a death, serious injury, or other significant adverse event is remote.However, the issue with the opening at the shaft-tip fusion is reportable.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and a high temperature was displayed.The catheter was removed and it was noted that there was blood in the catheter handle after it was removed from the patient and blood dripped out of the catheter.The returned device was visually inspected and it was found some kinks along the shaft, the shaft-tip fusion was found open with reddish brown material inside, internal parts were exposed and the connector was dark reddish material, which made this complaint mdr reportable.Then the returned device was then evaluated for electrical resistance and the thermocouple test failed and it was observed current leakage on all electrodes.A flow test was performed and the catheter failed, the catheter was not flushing correctly.The handle was opened and it was observed that the thermocouple wire was separate from the solder joint and reddish material was on the electrical pc board creating the electrical problem.A meeting with the manufacturing team was performed to investigate this issue and it was found that this issue is not related to the manufacture process since the open transition showed polyurethane donuts and the separation showed elongation.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 customer complaint has been verified.The root cause of the damage observed and the thermocouple wire breakage from the solder joint cannot be determined.The reddish material was introduced by the area damage causing the electrical malfunction.

• 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: 6712269
• MDR Text Key: 80273375
• Report Number: 9673241-2017-00573
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: (01)10846835008500(11)160816(17)190731(10)17545459M
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: D-1266-01-S
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 17545459M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 07/13/2017
• Supplement Dates Manufacturer Received: 02/10/2017
• Supplement Dates FDA Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2016
• 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