MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133602

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device 30010581m number, and no non-conformances were found during the review.Initial reporter phone: (b)(6).Manufacturer¿s ref # (b)(4).

Event Description

It was reported a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and a broken catheter tip issue occurred.It was reported that when the nurse opened the thermocool® smart touch¿ electrophysiology catheter, it was noticed that the catheter tip was broken.There is no information on what resolved the issue.No patient consequences were reported.The issue of broken catheter tip has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

On 6/11/2019, biosense webster inc.Received additional information indicating the event date was actually (b)(6) 2019 and not (b)(6) 2019 as previously reported.As such, the date of event has been updated with (b)(6) 2019.Manufacturer¿s ref #: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8426864
• MDR Text Key: 139233198
• Report Number: 2029046-2019-02830
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• 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: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Catalogue Number: D133602
• Device Lot Number: 30010581M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1