MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D133602

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

Patient Problems Arrhythmia (1721); No Code Available (3191)

Event Date 06/26/2020

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).

Event Description

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and suffered complete atrioventricular (av) heart block requiring surgical intervention.During the procedure, complete av heart block was discovered while monitoring the ablation pass.The medical intervention provided was a temporary pacemaker implantation.The patient was reported in stable condition after the intervention.Patient¿s av conduction recovered to normal pr interval several hours after the procedure ended.No permanent medical measures were necessary.It is unknown if 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 patient condition related.No bwi product malfunctions were reported.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2020.The device evaluation summary was completed on (b)(6)2020.It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter.During the procedure, complete av heart block was discovered while monitoring the ablation pass.The medical intervention provided was a temporary pacemaker implantation.The patient was reported in stable condition after the intervention.Patient¿s av conduction recovered to normal pr interval several hours after the procedure ended.No permanent medical measures were necessary.It is unknown if extended hospitalization was required as a result of the adverse event.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.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The catheter passed all the specifications.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.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 ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10296428
• MDR Text Key: 199533344
• Report Number: 2029046-2020-00899
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

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: 01/09/2021
• Device Model Number: D133602
• Device Catalogue Number: D133602
• Device Lot Number: 30326571M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention