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

Catalog Number D134805

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation on 4/9/2019.Initial visual analysis observed the returned thermocool® smart touch® sf bi-directional navigation catheter is slightly deflected.This finding has been assessed as mdr reportable.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.A manufacturing record evaluation was performed for the finished device 30160028l number, and no internal action was found during the review.Manufacturer¿s ref # (b)(4).

Event Description

It was reported a patient underwent an idiopathic ventricular tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the deflection became stuck.It was reported that while mapping the left outflow tract, the thermocool® smart touch® sf bi-directional navigation catheter became stuck in a deflected position due to a "broken puller wire".The physician, with some effort, was able to safely remove the catheter without harm to the patient.No patient consequence was reported.The customer later clarified that the catheter was fixed in full deflection while in the cardiac cavity but was partially straightened after pulling through the fastcath 8.5f sheath.The knob was able to be turned okay and another physician was able to move the thermocool® smart touch® sf bi-directional navigation catheter and release some of the curve by pulling back until it was safely removed from the patient¿s body.No physical damage was noted on the catheter except for the curve failure.No patient consequence was reported.The issue of deflection getting stuck has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

It was reported a patient underwent an idiopathic ventricular tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the deflection became stuck.It was reported that while mapping the left outflow tract, the thermocool® smart touch® sf bi-directional navigation catheter became stuck in a deflected position due to a "broken puller wire".The physician, with some effort, was able to safely remove the catheter without harm to the patient.No patient consequence was reported.Device evaluation details: on 5/9/2019, the device evaluation was completed.The device was inspected and the catheter was found slightly deflected however, during the second visual inspection it was clarified that the tip was found kinked.A deflection test was performed and it was found within specifications, the catheter was deflecting correctly.A tilt test was performed and the catheter was found out of specifications.A manufacturing record evaluation was performed and no internal action related to the reported complaint were identified.The customer complaint was not confirmed since the deflection mechanism was found within manufacture specifications, the kinked observed could be related to the customer complaint.The root cause of the kinked condition observed 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.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: 8547955
• MDR Text Key: 145962002
• Report Number: 2029046-2019-03027
• 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
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

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: 12/17/2019
• Device Catalogue Number: D134805
• Device Lot Number: 30160028L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 05/09/2019
• Supplement Dates FDA Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1