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

Catalog Number D134805

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2019

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 30248373m number, and no internal action related to the complaint was found during the review.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® sf bi-directional navigation catheter and a thrombus issue occurred.It was reported that during atrial fibrillation (afib) ablation procedure impedance became high and when the thermocool® smart touch® sf bi-directional navigation catheter was removed from the patient¿s body and checked, there was a thrombus adhesion at the catheter tip.The event occurred 1 hour after the thermocool® smart touch® sf bi-directional navigation catheter was started to be used during posterior wall isolation.The issue was resolved by changing the catheter to another one.The procedure was completed without patient's consequence.The customer¿s reported issue of high impedance is not reportable since the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.This event has been assessed as mdr reportable for the thrombus issue.

Manufacturer Narrative

On (b)(6)2019 , biosense webster inc.Received additional information indicating that there were no error messages or any product problems.The patient has not exhibited any neurological symptoms since the procedure.Additionally it was reported that the device is not available for return, therefore, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9269077
• MDR Text Key: 195043203
• Report Number: 2029046-2019-03835
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• 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: 10/08/2019

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: 06/21/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30248373M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 11/01/2019
• Supplement Dates Manufacturer Received: 12/25/2019
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1