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 Problems Break (1069); Crack (1135); Electrical /Electronic Property Problem (1198); Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a navistar rmt thermocool catheter and bad partial electrocardiogram (ecg) noise was seen, eeprom data errors occurred and the shaft of the catheter was broken inside of the patient.It was reported that all body surface (bs) and intracardiac (ic) ecg signals were lost on the carto 3 system and on the recording system.It was also reported the errors 7 (current leakage detected), eeprom, 101, and 1201 were displayed on the carto 3 system.Upon disconnecting the cable, they noticed that it had blood on it.It was also reported that the catheter end was dripping blood and that upon visual inspection a crack was noticed on the catheter shaft.The cable was replaced with no resolution.When the catheter was replaced, the issues resolved and the case was completed with no patient consequence.Upon request, additional information was provided on the event.All of the issues noted happened during the procedure.The physician was able to monitor the patient¿s heart rhythm from the defibrillator and the anesthesia monitor.As for the crack in the catheter shaft, it was less than half the length of the catheter from the handle with no wires exposed.There was no difficulty in removing the catheter.Even though the loss of signal was on all bs and ic ecgs as well as the carto 3 system and recording system, the physician was able to monitored patient's heart rhythm on the defibrillator and anesthesia monitor.This issue is therefore, not reportable.The errors that were displayed on the carto 3 system are highly detectable and pose low risk to the patient; therefore, they are also not reportable.Due to the compromise of the integrity of the catheter (crack on the shaft), this complaint is being reported.

Manufacturer Narrative

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.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a navistar rmt thermocool catheter and bad partial electrocardiogram (ecg) noise was seen, eeprom data errors occurred and the shaft of the catheter was broken inside of the patient.The returned device was visually inspected upon receipt and it was found that the catheter pins were damaged and have a reddish brown material on the connector.Continuing with the visual inspection catheter tip shaft transition was found cracked open, this condition might have contributed to the reddish brown material getting inside the device and cause the electrical catheter malfunction reported by the customer due to the foreign material covered all the internal components located at the catheter handle.A scanning electron microscope (sem) analysis was performed over the damaged tip-shaft area and results showed that the tip body presented evidence of elongations that suggest possible stretching/pulling until separation.Further information received indicates that there was no difficulty experienced while removing the catheter.A fourier transform infrared spectroscopy (ft-ir) analysis was performed on the catheter adhesive and the ir data obtained from the particles analyzed, revealed that the residue exhibited a higher similarity with a cured adhesive than the fresh adhesive observed.No other complaints have been received for the lot number involved on this complaint.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.All the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage/defect from leaving the facility.The customer complaint has been verified.The root cause of the catheter tip breakage could not be determined.

• 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: 4443295
• MDR Text Key: 20756627
• Report Number: 2029046-2015-00012
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: D-1266-01-S
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 17061963M
• Other Device ID Number: (01)10846835008500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2014
• 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