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

Model Number D134701

Device Problems Electrical Shorting (2926); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 12/01/2020

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

Event Description

It was reported that a female patient underwent cardiac ablation procedure for atrial fibrillation (afib) with thermocool® smart touch® sf uni-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During an afib ablation procedure the blood pressure was decreasing slowly, an echo showed pericardial infusion and a cardiopulmonary reanimation was needed.The patient underwent pericardiocentesis and intubation with mechanical ventilation.Medication was given to stop the bleeding.After approximately 15-20 min the patient was in stable condition.The patient was shifted to the intensive care unit ward.The physician thought that a perforation was caused at the roof of the left atrium while mapping with the thermocool® smart touch® sf uni-directional navigation catheter.No device and system malfunction was reported.The event occurred during the use of biosense webster products.The physician¿s opinion is that the cause of the event was procedure.The patient required hospitalization due to intubation.The patient¿s condition was improved.Dashboard, vector and visitag were used for force visualization.Visitag settings range: 3mm, time: 3 sec and tag size 3 mm.Time for coloring option.Warning at 50 gram.There was no evidence of steam pop.The irrigation flow settings were 2 ml during mapping and 20ml during ablation.

• 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: 11085653
• MDR Text Key: 224125308
• Report Number: 2029046-2020-01999
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• 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: 12/01/2020
• 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
• Treatment: CARTO 3 SYSTEM; LASSO NAV 2515,12P SPLITHANDLE
• Patient Outcome(s): Life Threatening; Required Intervention