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

Catalog Number D134805

Device Problems Crack (1135); Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation was performed for the finished device 30104484l number, and no internal actions was found during the review.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and it was reported that the pebax was broken with internal parts exposed.Initially, it was reported that during right pulmonary vein (rpv) ablation, the thermocool® smart touch® sf bi-directional navigation catheter could not be deflected as intended.The issue was resolved by changing the catheter to another one.The procedure was completed without patient's consequence.The biosense webster, inc.Product analysis lab received the device back for evaluation on (b)(6) 2019 and it was noted that ring #1 on the proximal side has the polyurethane (pu) margin peeling approximately 4.5 mm from distal end of the tip dome.The pebax sleeve has damage with metal exposed, approximately 8 mm from distal end of the tip dome.Ring #2 and ring #3 have scratches on them.The tip lumen has bumps approximately 2.1 cm and 2.3 cm from the distal of the tip dome.The issue of pebax cracked/broken was assessed as a reportable event.The issue of electrode damaged without foreign material without sharp/ rough edges was assessed as a not reportable event.The issue of deflection was assessed as a not reportable event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

After further evaluation on june 3, 2019, it was clarified that the electrode edge was not covered with pu (polyurethane) in a small area.This issue of electrode damage was assessed as a reportable event.The awareness date for this issue is june 3, 2019.Investigation summary: it was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation.It was reported that during right pulmonary vein (rpv) ablation, the thermocool® smart touch® sf bi-directional navigation catheter could not be deflected as intended.The issue was resolved by changing the catheter to another one.The procedure was completed without patient's consequence.The device was visually inspected and the pu (polyurethane) margin of ring #1 was observed peeling and the pebax was found damaged with exposed parts.In addition, ring #2 and ring #3 were observed to be scratched.During the second visual inspection, it was clarified that the electrode edge was not covered with pu (polyurethane) in a small area.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, 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 action was created to investigate this issue.The root cause of the damage on pebax and the damage on the electrode edge 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 reference # (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: 8570602
• MDR Text Key: 145788315
• Report Number: 2029046-2019-03050
• 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: 03/08/2019

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: 09/06/2019
• Device Catalogue Number: D134805
• Device Lot Number: 30104484L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 06/03/2019
• Supplement Dates FDA Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1