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

Model Number D134701

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 11/11/2020

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.A 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.(b)(4).Manufacturer's ref.# (b)(4).

Event Description

It was reported that a (b)(6) female patient underwent an atrioventricular nodal reentrant tachycardia (avrnt) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and suffered atrioventricular (av) heart block requiring surgical intervention (pacemaker implantation).During the procedure, the physician was using a catheter that is contraindicated for use, they have used the catheter before in the right atrium (ra).During the ablation, they were close to the his, while burning at 10-20 watts, the patient had a few missed beats and the physician stopped burning; however, the beats did not come back.The patient's coronary sinus and the right ventricle were then paced.The physician then tried to contact the emergency contact person for permission to place a pacemaker in the patient.The physician had a difficult time contacting the emergency contact person.The physician felt it was necessary to place a temporary pacemaker in the patient.The patient was stable during the procedure and during the placement of the temporary pacemaker.Patient was sent to the intensive care unit (uc) and stayed overnight for observation; her condition did not change.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related.No bwi product malfunctions were reported.

• 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 dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 10971523
• MDR Text Key: 220428027
• Report Number: 2029046-2020-01899
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2020

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 Model Number: D134701
• Device Catalogue Number: D134701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/08/2020
• 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): Life Threatening; Required Intervention
• Patient Age: 25 YR