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

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30433095m number, and no internal action 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)(6).(b)(4).Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure for ventricular tachycardia (vt) with thermocool® smart touch® sf bi-directional navigation catheter and suffered st-segment elevation requiring medication.Three hours since the beginning of the procedure, during epicardial ablation for ventricular tachycardia an st-segment elevation was observed.Immediately, ablation was stopped and coronary angiography (cag) was performed and medication was administered.No abnormalities with the ablation catheter were observed before and during use.The physician commented that there might have been too much ablation delivered near the coronary arteries.There was no report of extended hospitalization.The patient is recovering.Since the event required medication treatment it will be considered reportable.Conservatively reporting under ablation catheter.

Manufacturer Narrative

On 2/15/2021, biosnese webster inc.Received additional information indicating the patient is a 73-year-old male.Patient¿s condition improved.The physician related the cause of the event to the procedure.It was also clarified that cardiac arrest was not observed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 11204576
• MDR Text Key: 227948313
• Report Number: 2029046-2021-00085
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

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: 09/10/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30433095M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 03/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR