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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Vascular Dissection (3160); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(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 and septal aneurysm puncture requiring no intervention.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.The physician commented that there might have been too much ablation delivered near the coronary arteries.The physician¿s commented that a septal aneurysm was punctured but the echo image is not ¿bad¿.After aneurysm puncture, vital signs were stable in the procedure.(blood pressure: around 100, spo2: 98% to 100%).No pericardial effusion was noted.Blood pressure decreased after the patient left the room but had returned to the 80 level by the time the patient left the room.The physician also commented the echo image is coarse and there is a safety issue.There was no report of extended hospitalization.The patient is recovering.Since the st-segment elevation required medication treatment it will be considered reportable.The event is conservatively reported under the ablation catheter.Since the septal aneurysm puncture did not require medical or surgical intervention to preclude permanent impairment of a body function or permanent damage, it will not be considered mdr reportable.

Manufacturer Narrative

On 1/25/2021, biosense webster inc.Received additional information about the patient and event.It was reported the patient was female, weighing 54kg.Extended hospitalization was not required.The patient is recovering, and her condition has improved.The physician also commented that the coarse echo image was coming from the siemens machine, not related to a bwi product.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

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.Device investigation details: on (b)(6) 2021, biosense webster inc.Received information indicating device has been discarded.As such, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30438429m 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.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: 11205226
• MDR Text Key: 227948937
• Report Number: 2029046-2021-00091
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30438429M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 54