MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

The biosense webster inc.Product analysis lab received the device for evaluation on 4/11/2019.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.A manufacturing record evaluation was performed for the finished device 30104056m number, and no non-conformances was found during the review.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch¿ electrophysiology catheter and the biosense webster, inc.Product analysis lab noted that the pebax sleeve was damaged.Initially, during the procedure, the temperature could not be displayed.The thermocool® smart touch¿ electrophysiology catheter was exchanged and the procedure was completed.There was no patient consequence reported.The temperature issue was assessed as not reportable.The ablation cannot be performed since there is no radio frequency energy applied.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and noted on april 11, 2019 that the helix spring was bent inside the pebax sleeve approximately 5 mm from the distal end of the tip dome.The pebax sleeve was damaged approximately 6 mm from the distal end of the tip dome.The pebax sleeve being damaged was assessed as a reportable issue as the integrity of the device was compromised.The awareness date of this reportable lab finding is april 11, 2019.

Manufacturer Narrative

Originally the pebax sleeve was described to have damage.Further clarification was provided on may 15, 2019 on the damage stating that the damage observed appeared to be a potential cut in the pebax sleeve.This damage on the pebax remains assessed as reportable.Additional testing was performed on may 15, 2019 and the scanning electron microscope (sem) analysis showed evidence of mechanical damage.Scratches, stress marks and several holes were observed on the pebax surface.It is possible that the damage was caused by an unknown object.No other anomalies were observed.The damage on the pebax remains assessed as reportable.Investigation summary: it was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch¿ electrophysiology catheter.During the procedure, the temperature could not be displayed.The thermocool® smart touch¿ electrophysiology catheter was exchanged and the procedure was completed.There was no patient consequence reported.The device was inspected and the helix spring was found bent and a cut appeared to be in the pebax.Then, a tilt test was performed and the tip was found out of specifications.Then, electrical test was performed and the catheter failed, no electrical readings were observed on electrode # 1.A failure analysis was performed and the catheter was dissected on the tip area, the electrical wire was found broken causing the improper electrical signal.In addition, the thermocouple values were found out of specification.A failure analysis was performed and it was found that there was an electrical intermittence on the tip area creating the temperature issue.Additionally, a scanning electron microscope (sem) testing was performed on the pebax area and the results showed evidence of mechanical damage.Scratches, stress marks and several holes were observed on the pebax surface.It is possible that damage was caused by an unknown object.No other anomalies were observed.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the electrical wire breakage and the damage on the catheter tip cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.The temperature issue does not represent any patient safety impact since the device is unable to deliver radio frequency energy to ablate.Manufacturer¿s reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8598257
• MDR Text Key: 145966243
• Report Number: 2029046-2019-03110
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

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: 08/29/2019
• Device Catalogue Number: D133604IL
• Device Lot Number: 30104056M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 05/15/2019
• Supplement Dates FDA Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1