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

Catalog Number D133604IL

Device Problems Crack (1135); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device was visually inspected and the pebax was found wrinkled up leaving the internal parts exposed, in addition, the peek housing tip transition was found damage with no internal parts exposed.Then, the deflection test was performed and the catheter failed.A failure analysis was performed and the catheter was observed under the x-ray machine and the t-bar was found slid down causing the improper deflection condition.A manufacturing record evaluation was performed for the finished device 30130474m number, and no internal action was found during the review.The customer complaint was confirmed.The root cause of the t-bar slippage cannot be determined, however, an internal corrective action has been opened to investigate the issue of the t-bar sliding down.The root cause of the damage on pebax 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 however, this cannot be conclusively determined.(b)(6).Manufacturer¿s ref # (b)(4).

Event Description

It was reported a patient underwent an atrial tachycardia (at) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab has identified the integrity of the device is compromised with internal part exposed approximately 8mm from the distal end of the tip dome.It was initially reported by the customer that during the procedure, the catheter could not be deflected to specification.A second catheter was used to complete the procedure.There was no patient consequence.The customer¿s reported issue of inadequate curve/deflection has been assessed as not mdr reportable since the potential risk that it could cause or contribute to a death, serious injury or other significant adverse event is remote.On 5/13/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis found the ¿pebax sleeve wrinkled up with internal part exposed approximately 8mm from the distal end of the tip dome.Transition between peek housing and the tip lumen has separation.¿ the findings have been reviewed and the issue of ¿internal part exposed¿ has been assessed as an mdr reportable malfunction.This event was originally considered nonreportable, however, bwi became aware of a reportable malfunction on 5/13/2019 during initial visual analysis.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8668738
• MDR Text Key: 150162404
• Report Number: 2029046-2019-03211
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2019
• Device Catalogue Number: D133604IL
• Device Lot Number: 30130474M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1