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

Model Number D134805

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Vascular Dissection (3160); No Code Available (3191)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a male patient underwent cardiac ablation procedure for idiopathic ventricular tachycardia (idvt) with thermocool® smart touch® sf bi-directional navigation catheter and suffered femoral artery dissection requiring surgical intervention.It was reported that during an idiopathic ventricular tachycardia case, a femoral artery dissection was noticed.After achieving retrograde access to the left ventricle (lv), they pulled out to go to the right side for further mapping, but when returning back to the left side, they could not advance the ablation or mapping catheter past the head of femur.The femoral artery dissection was discovered when contrast dye was injected into the patient.It was confirmed by fluoro x-ray.The medical intervention provided was vascular surgery, and 2 stents were applied.The procedure was aborted.The patient was reported to be in stable condition.The physician considered procedure as the cause of the event.Dissection suspected to be caused by guidewire in femoral artery and possibly made worse by removal of pentaray from artery.The patient had fully recovered.Extended hospitalization was not required, the patient went home following day which was the original plan.Since the vascular dissection required surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is mdr-reportable.

Manufacturer Narrative

On 11/24/2020, rhe bwi 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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On (b)(6) 2020, the product investigation was completed.It was reported that a male patient underwent cardiac ablation procedure for idiopathic ventricular tachycardia (idvt) with thermocool® smart touch® sf bi-directional navigation catheter and suffered femoral artery dissection requiring surgical intervention.It was reported that during an idiopathic ventricular tachycardia case, a femoral artery dissection was noticed.After achieving retrograde access to the left ventricle (lv), they pulled out to go to the right side for further mapping, but when returning back to the left side, they could not advance the ablation or mapping catheter past the head of femur.The femoral artery dissection was discovered when contrast dye was injected into the patient.It was confirmed by fluoro x-ray.The medical intervention provided was vascular surgery, and 2 stents were applied.The procedure was aborted.The patient was reported to be in stable condition.The physician considered procedure as the cause of the event.Dissection suspected to be caused by guidewire in femoral artery and possibly made worse by removal of pentaray from artery.The patient had fully recovered.Extended hospitalization was not required, the patient went home following day which was the original plan.Device evaluation details: the device was visually inspected and it was found in good conditions.The magnetic, temperature and force features were tested and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30405021m lot number, and no internal actions related to the reported complaint condition were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown; however, the physician considered procedure as the cause of the event.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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: 10837627
• MDR Text Key: 216194873
• Report Number: 2029046-2020-01690
• 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,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30405021M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PENTARAY CATHETER; PENTARAY CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 56 YR