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 Complete Heart Block (2627); No Code Available (3191)

Event Date 05/29/2020

Event Type  Injury  

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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a (b)(6)-year-old male patient ((b)(6) kg) underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered complete atrioventricular heart block requiring surgical intervention.During the end of ablation, a complete av heart block was discovered via heart rate/conduction change as the patient shown signs of bradycardia.Av heart block was confirmed by ekg.A permanent pacemaker implantation was required.The patient stayed overnight for observation purposes.Patient¿s condition unchanged.Normal conduction did not recover.The physician stated the event may have been a mapping issue not related to the equipment.Physician contributes complication to anatomy- review of signal shows prior his potential.No biosense webster inc.Product malfunctions were reported.

Manufacturer Narrative

On (b)(6)2020 , the product investigation was completed.It was reported that a 60-year-old male patient (95kg) underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered complete atrioventricular heart block requiring surgical intervention.During the end of ablation, a complete av heart block was discovered via heart rate/conduction change as the patient shown signs of bradycardia.Av heart block was confirmed by ekg.A permanent pacemaker implantation was required.The patient stayed overnight for observation purposes.Patient¿s condition unchanged.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.Then, electrical test was performed and the catheter failed, no electrical readings were observed on electrode #5.A failure analysis was performed and the catheter was dissected on the tip area, the electrical wire was found broken causing the improper electrical signal.A manufacturing record evaluation was performed for the finished device 30329540m number, and no internal actions related to the reported complaint condition were identified.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.The root cause of the electrical wire breakage cannot be determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Correction: it was also noticed that field "b2.Is other serious" was inadvertently left blank int he 3500a initial mdr.The field has now been checked.Manufacturer's reference number: pc-000705194.

• 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: 10187225
• MDR Text Key: 198723980
• Report Number: 2029046-2020-00748
• 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: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30329540M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 95