MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D132705

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.The device was inspected and the peek housing tip transition was found cracked with some red brown material inside and metal exposure.Also, bumps were observed on the catheter tip.Then, a 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 and no internal actions related to the reported complaint were identified.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.(b)(6).Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter for which biosense webster¿s product analysis lab has identified a crack in the peek housing and tip lumen exposing the internal components.The customer initially reported that during the procedure the thermocool® smart touch¿ bi-directional navigation catheter could not be deflected as intended.The catheter was changed to another one and the procedure was completed without patient consequence.The customer¿s reported deflection issue is not mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.On 8/15/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual inspection found ¿the transition between the peek housing and lumen tip is cracked open with some red-brown material inside and metal exposed.Bumps on the tip lumen approximately 1.7 cm and 1.9 cm from the distal end of the tip dome.¿ these findings were reviewed and determined that the observed ¿crack¿ is mdr reportable since integrity of the device is compromised by exposing internal metal components.The bumps on the shaft without exposed internal components are not mdr reportable since the integrity of the device is maintained and the risk of serious injury is remote.This event was originally considered nonreportable, however, bwi became aware of a reportable malfunction through visual analysis on 8/15/2019 and has reassessed this complaint as reportable.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 8972718
• MDR Text Key: 157879669
• Report Number: 2029046-2019-03610
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031/S053
• 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: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2019
• Device Catalogue Number: D132705
• Device Lot Number: 30143205M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Date Manufacturer Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1