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

Model Number D132704

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Vascular Dissection (3160); No Code Available (3191)

Event Date 08/31/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).The 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure on (b)(6) 2020 with a thermocool® smart touch¿ bi-directional navigation catheter and vessel dissection (requiring surgical intervention) and death.Initially it was reported that during the procedure, the catheter was bent and was not deflecting properly to the f curve.The catheter was replaced, and the issue resolved.No patient consequence was reported.The reported deflection issue was assessed as not mdr reportable.Insufficient deflection or not relaxing completely (without stuck in the deflected position) would cause intraprocedural delay.The potential risk that it could cause or contribute to a death or serious injury was remote.Additional information was received on (b)(6) 2020.Post-procedure while the patient was in recovery, the patient had developed some internal bleeding.It was believed the patient had an aortic dissection; however, it is unknown how the dissection was discovered or confirmed.It had been noted that the patient had been stable throughout the procedure.Additional surgeries were required.It was reported that the patient died on (b)(6) 2020.No further information is available.Physician causality opinion was not provided.Any product malfunction or serious injury that results in patient¿s death is to be considered serious and mdr-reportable.The awareness date for the report table adverse event is (b)(6) 2020.

Manufacturer Narrative

On 10/1/2020, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure on (b)(6) 2020 with a thermocool® smart touch¿ bi-directional navigation catheter and vessel dissection (requiring surgical intervention) and death.Initially it was reported that during the procedure, the catheter was bent and was not deflecting properly to the f curve.The catheter was replaced, and the issue resolved.No patient consequence was reported.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, and no internal actions related to the reported complaint were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.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 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: 10603943
• MDR Text Key: 209112656
• Report Number: 2029046-2020-01360
• 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
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2021
• Device Model Number: D132704
• Device Catalogue Number: D132704
• Device Lot Number: 30373117M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention