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

Model Number D134805

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

Patient Problems Cardiac Arrest (1762); Complete Heart Block (2627); No Code Available (3191)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a male patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered atrioventricular heart block and asystole requiring pacemaker implantation.During the procedure, the soundstar catheter showed calibration error message 6102.All cables and catheters were disconnected and reconnected from the front of the patient interface unit, but the issue remained.The catheter was replaced, and the issue resolved.It was also reported that during the procedure while using the thermocool® smart touch® sf bi-directional navigation catheter, the patient went into av heart block and became asystolic.The block was confirmed by electrocardiogam.The medical intervention provided was a permanent pacemaker.The patient was reported in stable condition after pacemaker implantation.Extended hospitalization was required as a result of the adverse event.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related.No biosense webster, inc.Product malfunctions were reported.The ultrasound recognition issue was assessed as not reportable.The incidence of ¿catheter /ultrasound recognition issue¿ is easily detectable by the user.The potential that it could cause or contribute to a death or serious injury was remote.Since this event is life threatening and required medical/surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, then the event it is to be considered serious and mdr-reportable.

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 30332019m number, 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.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: 10204485
• MDR Text Key: 197113439
• Report Number: 2029046-2020-00772
• 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
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30332019M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOUNDSTAR ECO GE 8F CATHETER; UNKNOWN BRAND CABLE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 68 YR