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 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

The product 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 ref.# (b)(4).

Event Description

On 8/15/2019, biosense webster inc.¿s (bwi) product analysis lab (pal) received a thermocool® smart touch¿ electrophysiology catheter which was identified to have a crack with the tip lumen material damaged exposing internal metal components of the catheter.Upon receiving the thermocool® smart touch¿ electrophysiology catheter, initial visual inspection found the ¿transition between the peek housing and tip lumen is cracked open with some red-brown material inside.The tip lumen material is damaged with metal exposed at proximally 20.3 cm from distal end of the tip dome.The integrity of the device is compromised which is considered an mdr reportable malfunction.The thermocool® smart touch® sf bi-directional navigation catheter was returned by the customer without a related complaint number.It was returned under another complaint for which it is not related.No specific malfunction is known.Multiple attempts have been made to obtain clarification for the product received, however, no specific complaint or product problem has been made available.A new complaint was created to investigate and report the malfunction although no specific event details are available.

Manufacturer Narrative

On 8/15/2019, biosense webster inc.¿s (bwi) product analysis lab (pal) received a thermocool® smart touch¿ electrophysiology catheter which was identified to have a crack with the tip lumen material damaged exposing internal metal components of the catheter.Upon receiving the thermocool® smart touch¿ electrophysiology catheter, initial visual inspection found the ¿transition between the peek housing and tip lumen is cracked open with some red-brown material inside.The tip lumen material is damaged with metal exposed at proximally 20.3 cm from distal end of the tip dome.The integrity of the device is compromised which is considered an mdr reportable malfunction.Device evaluation details: the device evaluation has been completed.The device was visually inspected, and it was found tip lumen material damaged with metal exposed a proximally 20.3 cm from distal end of the tip dome.Then, deflection test was performed, and the catheter failed.A failure analysis was performed, and the catheter was observed within the x ray machine and the t bar was found slid down causing the improper deflection condition.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 damage on tip and t bar slippage 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 handling of the device during the procedure, however, this cannot be conclusively determined.However, an internal corrective action has been opened to investigate the issue of the t bar sliding down.Manufacturer¿s ref # (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: 8972964
• MDR Text Key: 157879016
• Report Number: 2029046-2019-03614
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

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: 02/19/2020
• Device Catalogue Number: D133604IL
• Device Lot Number: 30177765M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/06/2019
• Supplement Dates Manufacturer Received: 09/24/2019
• Supplement Dates FDA Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1