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

Model Number D134805

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

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226); Respiratory Failure (2484)

Event Date 06/07/2021

Event Type  Death  

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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a female patient, born on (b)(6) 1940, underwent an atrial fibrillation (afib)/ left sided atypical micro flutter ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis, respiratory failure, and cardiac arrest which required the patient to be placed on a bipap machine.The patient expired.There were no issues reported during the case.The case was done under general anesthesia and there was no mention of reduced blood pressure during the case.There were no errors nor malfunctions noted with the product.The case was completed without any complication.No concern was expressed by the physician.The patient left the room in stable condition.The physician received a call from the recovery room that the patient had no pressure and believed it to be respiratory in etiology.The patient was hooked up to a bipap machine and was taken to the intensive care unit (icu).The support team was called in and pericardiocentesis was performed.The patient eventually passed away.The physician¿s opinion regarding the cause of this adverse event is that this was patient condition related and the physician believed that the death was due to a respiratory-related issue.It was noted that this patient had a medical history of atrial fibrillation.Force visualization features used were graph, dashboard, vector, visitag.The visitag module was used and the parameters for stability were: 2.5mm for 3 seconds with respiratory adjusted and color visitag options: total time (custom 5-10 seconds).

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12123165
• MDR Text Key: 260098742
• Report Number: 2029046-2021-01049
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: Other
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2021
• 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
• Removal/Correction Number: Z-0055-2018
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; UNK GE CARDIO LAB; UNKNOWN DECANAV CATHETER; UNKNOWN VIVID IQ ULTRASOUND SYSTEM; UNK_LASSO; UNK_SMARTABLATE GENERATOR; UNK_SOUNDSTAR
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 80 YR