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

Catalog Number D133604IL

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2019

Event Type  malfunction  

Manufacturer Narrative

The biosense webster inc.Product analysis lab received the device for evaluation on november 15, 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.Manufacturer's reference # (b)(4).

Event Description

It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and the biosense webster, inc.Product analysis lab discovered that the distal tip was bent and partially detached.Initially it was reported that during the procedure, the catheter could not deflect to its specifications.The issue was resolved by changing the catheter to another one.The procedure was completed without patient's consequence.The curve inadequate issue was assessed as not reportable.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.The initial visual inspection of the product revealed that distal tip was bent and partially detached.During the second visual inspection on november 25, 2019, the device was inspected, and it was confirmed that distal tip was bent and partially detached.It was also found there was polyurethane was observed on the edges.It was confirmed that the integrity of the device was compromised.These findings were reviewed and determined to be mdr reportable as a malfunction.This event was originally considered not mdr reportable, however, biosense webster, inc.Became aware of a reportable malfunction through visual analysis and testing on november 15, 2019 and have reassessed this complaint as reportable.Therefore, the awareness date for this reportable lab finding is november 15, 2019.

Manufacturer Narrative

Investigation summary it was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and the biosense webster, inc.Product analysis lab discovered that the distal tip was bent and partially detached.Initially it was reported that during the procedure, the catheter could not deflect to its specifications.The issue was resolved by changing the catheter to another one.The procedure was completed without patient's consequence.The device was inspected, and the distal tip was found partially detached.In addition, polyurethane (pu) was observed on the edge.A deflection test was performed, and the catheter passed.A manufacturing record evaluation was performed for the finished device 30163225m number, and no internal actions related to the reported complaint condition were identified.Additionally, the customer provided a photo of the product box.An evaluation was performed; however, no result can be obtained from it.The customer complaint cannot be confirmed.The root cause of the damage on the tip could be related to the shipping/handling of the device however, this cannot be conclusively determined.Manufacturer's reference # (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: 9447898
• MDR Text Key: 199481102
• Report Number: 2029046-2019-03979
• 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: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2020
• Device Catalogue Number: D133604IL
• Device Lot Number: 30163225M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Date Manufacturer Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1