MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THMCL SMARTTOUCH,TC,D,C3,OBL; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

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 and no internal actions were found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool® smart touch¿ electrophysiology catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found the distal tip kinked with a slit exposing the t bar metal.Initially, it was reported that during ablation, the catheter would not deflect to specification.A second catheter was used to complete the operation.No adverse patient consequences were reported.The observed deflection issue has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The bwi pal received the device for evaluation.Upon initial inspection, the pal observed a kink 11 cm from the distal tip.The observed kink has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.Further testing was performed.On 11/21/2019, a second visual inspection was performed.The bwi pal found a kink 11 cm from the distal tip with slit exposing t bar metal.The observed slit has been assessed as an mdr reportable malfunction as the device integrity was compromised.The awareness date has been reset to 11/21/2019.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool® smart touch¿ electrophysiology catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found the distal tip kinked with a slit exposing the t bar metal.The investigational analysis completed 1/10/2020.The device was inspected and shaft was kinked.During the second visual, the kinked shaft was confirmed and the t -bar metal was observed exposed.Deflection testing was performed and the catheter failed.A failure analysis was performed and the catheter was observed under the x ray machine.The t bar was found slipped down causing the improper deflection condition.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint was confirmed.The root cause of the t-bar metal exposed is related with the t-bar slipped.There was a previous investigation to reduce t bar slippage issue and it could be related to the usage of the device.Manufacture reference no: (b)(4).

• Brand Name: THMCL SMARTTOUCH,TC,D,C3,OBL
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9471198
• MDR Text Key: 199482301
• Report Number: 2029046-2019-03998
• 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: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2020
• Device Catalogue Number: D133604IL
• Device Lot Number: 30163261M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1