MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133602

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 6/7/2018.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.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.Concomitant medical products: smart ablate generator (model#: m49002, serial#: unknown).Manufacturer ref no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch¿ electrophysiology catheter, and the catheter displayed a high impedance.Accumulated light red liquid observed in the shaft of the catheter sensor around the tip was also reported.Physician's opinion is that he does not think it is char and that blood was observed in the catheter shaft.Saline anticoagulant was administered to the patient.The catheter was replaced and procedure completed without patient consequence.Settings during the event include: generator parameters set to power mode with a temperature cut off set at 42° celsius.No error messages were observed, but within seconds of radio frequency (rf) coming on, the smartablate (sa) would shut off due to high impedance.There was product problem upon removing it from the body for assessment.There were no issues related to temperature and flow on the catheter.Patient has not exhibited any neurological symptoms since the procedure was completed.High impedance and blood is not reportable.The potential it could cause or contribute to a serious injury or death is remote.Therefore, the high impedance and blood in the catheter shaft was originally assessed as not reportable.This event is being reported because the bwi failure analysis lab received the device for evaluation and on (b)(6) 2018 discovered red residue in the clear pebax sleeve and a hole in the clear pebax approximately 0.6 cm from distal tip.The finding of a hole in the pebax has been assessed as a reportable malfunction.The awareness date has been reset to june (b)(6) 2018.

Manufacturer Narrative

Device evaluation summary: the device was visually inspected upon receipt, and a hole was observed on the pebax with light red material inside.An electrical test was performed on the catheter, which was found within specifications.However, the thermocouple values were found out of tolerance.Failure analysis was performed, and it was found that there was an electrical intermittence on the tip area, creating the temperature issue.The catheter was connected to a stockert radiofrequency generator to test the impedance values, which were within specifications.The magnetic sensor functionality was tested in conjunction with a carto 3 system, and the catheter was properly visualized with no errors.A force sensor test could not be performed due to the temperature issue; however, no errors were observed during the carto test.Deflection and irrigation tests were performed, which the catheter passed.Scanning electron microscope (sem) analysis was performed on the damaged area of the pebax, and the results showed evidence of mechanical damage, stress marks and confirmed the hole.It is possible that the damage was generated by contact with an unknown object.No other anomalies were 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 specifications and procedures.During the manufacturing process, all catheters are inspected for visual damage prior to packaging.On-line inspections and functional tests are in place to prevent catheters with this type of damage from leaving the facility.The customer report of blood around the tip was confirmed, but the impedance values were found within specification.The root cause of the pebax damage cannot be determined, since there is evidence that the device was manufactured in accordance with documented specification and procedures.The thermocouple failure is detectable in production; however, the wires can break intraoperatively as a result of the manipulation of the device.This failure does not represent any patient safety impact.Manufacturer¿s reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7664546
• MDR Text Key: 113310397
• Report Number: 2029046-2018-01764
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Catalogue Number: D133602
• Device Lot Number: 17772090M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Date Manufacturer Received: 07/26/2018
• Patient Sequence Number: 1