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

Model Number D134805

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Vascular Dissection (3160); No Code Available (3191)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

"no code available" is being used for surgical intervention.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 patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and suffered vascular dissection (aortic dissection) requiring surgical intervention (stent placement).During the procedure an aortic dissection was found.The physician had difficulty advancing the ablator up the aorta, so the physician shot contrast and found a small aortic dissection.The physician did not confirm on intracardiac echocardiography (ice).The medical intervention provided was a stent implantation, and the procedure continued as normal.The patient was reported to be in stable condition.It is unknown if extended hospitalization was required.Physician¿s causality opinion was not provided.No bwi product malfunctions were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since this event is life threatening and required surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, then it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 11/24/2020, the product investigation was completed.It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and suffered vascular dissection (aortic dissection) requiring surgical intervention (stent placement).During the procedure an aortic dissection was found.The physician had difficulty advancing the ablator up the aorta, so the physician shot contrast and found a small aortic dissection.The physician did not confirm on intracardiac echocardiography (ice).The medical intervention provided was a stent implantation, and the procedure continued as normal.The patient was reported to be in stable condition.It is unknown if extended hospitalization was required.Physician¿s causality opinion was not provided.No bwi product malfunctions were reported.Device investigation details: the device was visually inspected and it 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 for the finished device 30410128m number, and no internal action related to the complaint was found during the review.The catheter passed all 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 SF UNI-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: 10687401
• MDR Text Key: 211876694
• Report Number: 2029046-2020-01484
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30410128M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention