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

Model Number D134701

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

Patient Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Initial reporter phone: (b)(6).(b)(4).

Event Description

It was reported that a female patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and suffered cardiac tamponade (requiring pericardiocentesis) and vascular dissection (requiring surgical intervention).During the procedure the left ventricle outflow tract (lvot) and right ventricle outflow tract (rvot) were mapped and ablated.During rvot map pericardial effusion was observed which was then confirmed.Pericardiocentesis was performed to drain an unspecified amount of fluid from the pericardial space.Coronary angiography and x-ray were then performed, and a left anterior descending (lad) coronary artery dissection was confirmed.The procedure was delayed by 60-90 minutes due to the issue experienced and could not be completed.Patient received a stent to reconnect the lad and required extended hospitalization of 2 days in the intensive care unit.The patient made a full recovery.Physician¿s opinion is that the dissection was caused by catheter movement but not due to a product malfunction itself.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10308779
• MDR Text Key: 200277595
• Report Number: 2029046-2020-00911
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134701
• Device Catalogue Number: D134701
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention