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

Model Number D134805

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure for persistent atrial fibrillation (afib) with a thermocool® smart touch® sf bi-directional navigation catheter and a knotted catheter issue occurred.The thermocool® smart touch® sf bi-directional navigation catheter looped onto itself while inside of the patient¿s body and was kinked when removed from the patient.The catheter did not get stuck in a fully deflected position.The physician was able to undo the loop under fluoroscopy and the catheter was able to be easily removed.The catheter was replaced, and the issue resolved.No physical damage to the distal end of the catheter such as rings damage was observed.No patient consequences were reported.The event was assessed as an mdr reportable knotted catheter issue.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation on (b)(6)2020.The device evaluation was completed on (b)(6)2020.It was reported that a patient underwent a cardiac ablation procedure for persistent atrial fibrillation (afib) with a thermocool® smart touch® sf bi-directional navigation catheter.The thermocool® smart touch® sf bi-directional navigation catheter looped onto itself while inside of the patient¿s body and was kinked when removed from the patient.The catheter did not get stuck in a fully deflected position.The physician was able to undo the loop under fluoroscopy and the catheter was able to be easily removed.The catheter was replaced, and the issue resolved.No physical damage to the distal end of the catheter such as rings damage was observed.No patient consequences were reported.The device was visually inspected and it was found a kink on the distal part of the shaft.A manufacturing record evaluation was performed and no internal action was found during the review.The customer complaint was confirmed.The root cause of the kink on the shaft cannot be determined.It could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.All units are inspected prior leaving the facility and the manufacturing record evaluation verified that this complaint unit was in good condition.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: 10939588
• MDR Text Key: 219358397
• Report Number: 2029046-2020-01851
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30435902M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; UNKNOWN BRAND BACK PATCH SENSOR CABLE; UNKNOWN BRAND BACK PATCH SENSOR CABLE; UNKNOWN BRAND CATHETER; CARTO 3 SYSTEM; UNKNOWN BRAND BACK PATCH SENSOR CABLE; UNKNOWN BRAND BACK PATCH SENSOR CABLE; UNKNOWN BRAND CATHETER