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

Model Number D132704

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Perforation of Vessels (2135); Vascular Dissection (3160)

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

On 4/15/2021, the bwi product analysis lab received the complaint device for evaluation.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a male patient underwent a premature ventricular contraction (pvc) ablation with a thermocool® smart touch¿ bi-directional navigation catheter and the patient suffered a vascular injury.While doing a left outflow track case with the thermocool® smart touch¿ bi-directional navigation catheter, the physician (fellow) decided they wanted to burn on the right-side outflow tract and the catheter was moved from the left side to the right side.In doing so, the thermocool® smart touch¿ bi-directional navigation catheter was accidentally contaminated and replaced.The new catheter was then advanced into the existing access on the right femoral vein and the catheter was meeting resistance.It was verified under fluoroscopy that the catheter was no longer in the lumen of the vein.The attending physician was made aware and vascular surgery was notified.The catheter was removed safely, and the patient was in stable condition.The patient was stable during the entire procedure.The case was aborted.The attending felt it was user error of the catheter insertion that was the root cause of the issue.The patient was reported to be fully recovered.

Manufacturer Narrative

It was reported that a male patient underwent a premature ventricular contraction (pvc) ablation with a thermocool® smart touch¿ bi-directional navigation catheter and the patient suffered a vascular injury.While advancing the thermocool® smart touch¿ bi-directional navigation catheter into the existing access on the right femoral vein and the catheter was meeting resistance.It was verified under fluoroscopy that the catheter was no longer in the lumen of the vein.The attending physician was made aware and vascular surgery was notified.The catheter was removed safely, and the patient was in stable condition.The patient was stable during the entire procedure.Device evaluation details: the device evaluation has been completed.Per the event, several tests were performed.The magnetic and force sensor functionality was tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.Electrical and generator test were performed and no malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.However, it could be related to the user error reported on the event description during the catheter insertion.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 4/27/2021, during an internal review of this file, it was determined that the patient adverse event should be considered ¿vessel perforation¿ and not ¿vascular dissection¿.As such, the h6.Health effect - clinical code has been corrected from vascular dissection (e0515) to perforation of vessels (e0511).Additionally, it was noticed that the concomitant product was inadvertently omitted from section d11.Concomitant med.Product section.It has now been added.

• Brand Name: THERMOCOOL SMART TOUCH 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: 11593752
• MDR Text Key: 245788621
• Report Number: 2029046-2021-00450
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: 10846835009194
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2021
• Device Model Number: D132704
• Device Catalogue Number: D132704
• Device Lot Number: 30471838M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 04/15/2021; 04/27/2021
• Supplement Dates FDA Received: 04/16/2021; 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THMCL SMRTTCH,BI,NAV,TC,F-J,C3
• Patient Outcome(s): Life Threatening; Required Intervention