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

Model Number D134804

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

Patient Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device lot# 30342323m, and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent ischemic ventircular tachycardia (isvt) ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention.Toward the end of the procedure epicardial access was obtained, with intent of ablating epicardially, and it was at that point that the effusion was diagnosed.A pericardiocentesis was performed and the patient was in route to the operation room (or) at the time of the call.The physician believed the effusion occurred when the coronary sinus (cs) was cannulated or during ablation within the cs.It was undetermined whether the physician believed that biosense webster products contributed toward the patient event or not.There was no report of extended hospitalization.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available in the future; the reportability decision will be reassessed.

Manufacturer Narrative

On(b)(6)2020 , the complaint device was received for evaluation.On (b)(6)2020 , the product investigation was completed.It was reported that a patient underwent ischemic ventircular tachycardia (isvt) ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention.Toward the end of the procedure epicardial access was obtained, with intent of ablating epicardially, and it was at that point that the effusion was diagnosed.A pericardiocentesis was performed and the patient was in route to the operation room (or) at the time of the call.The physician believed the effusion occurred when the coronary sinus (cs) was cannulated or during ablation within the cs.It was undetermined whether the physician believed that biosense webster products contributed toward the patient event or not.There was no report of extended hospitalization.Device evaluation details: the device was visually inspected, and it was found in good normal conditions.The magnetic, temperature and force features were tested, and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.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 states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The catheter passed specification.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-000723442.

• 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: 10322289
• MDR Text Key: 200474681
• Report Number: 2029046-2020-00937
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: 07/01/2020

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: 02/04/2021
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30342323M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 08/10/2020
• Supplement Dates FDA Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention