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 Ventricular Fibrillation (2130); Respiratory Failure (2484)

Event Date 03/08/2022

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.A manufacturing record evaluation was performed for the finished device 30673723 number, and no internal action related to the complaint was found during the review.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 (b)(6) year-old male patient ((b)(6) kgs) patient underwent a non-ischemic ventricular tachycardia (non-isvt ¿ right)/ premature ventricular contraction (pvc) ablation in the aortic cusps/mitral annulus ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered respiratory failure, ventricular fibrillation and death.The patient had a significant medical history of congestive heart failure (chf), ejection fraction (ef) of 20%, alcohol (etoh) abuse, cardiomyopathy, bi ventricular implantable cardioverter-defibrillator (biv icd) and pulmonary fibrosis.The patient was having a pvc ablation at the right/left cusp junction of the aorta.After successful ablation of the pvc, post ablation waiting period ensued.During this time it was noted the patient began to develop work of breathing.He was not under general anesthesia, rather monitored anesthesia care (mac) sedation.After some efforts by anesthesia to improve patient status, his arterial line tracing began to show low blood pressure.Despite the intervention, the patient was intubated and vasopressors were given to the patient but the patient continued to decompensate.The patient then went into ventricular fibrillation arrest.At this time advanced cardiac life support (acls) protocol was initiated and code blue was called.An interventional cardiologist, assisted by inserting an impella assistive device.During the code many resuscitative medications were given with little effect.The physician performed several sweeps of the heart with intracardiac echo which showed no effusion, prior to removing the catheters.Many shocks for vf were delivered each with brief return of sinus rhythm, followed by deterioration to vf again.After successful placement of the impella catheter into the left ventricle (lv) a transthoracic echo was performed to verify placement and function, again showing no pericardial effusion.Despite all these efforts the patient was pronounced dead after about 1.5 hours of resuscitation attempts on (b)(6) 2022.The adverse event was discovered post use of biosense webster products.The generator used in the case was smart ablate.In physician¿s opinion, what was the cause of death was respiratory arrest.All deaths were bwi fda approved ¿ ce mark devices are involved are reportable.

Manufacturer Narrative

On (b)(6) 2022, the bwi medical safety officer assessed the event and made the following determination: "review of the description of this event suggests that the patient suffered an induction of a life-threatening ventricular fibrillation and respiratory arrest.An interventional cardiologist, assisted by inserting an impella device.The patient had a significant medical history of congestive heart failure (chf), ejection fraction (ef) of 20%, alcohol (etoh) abuse, cardiomyopathy, bi ventricular implantable cardioverter-defibrillator (biv icd) and pulmonary fibrosis.The physician reports that cause of death was related to respiratory arrest.There was no errors or malfunctions noted with bwi products." 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 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 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13935578
• MDR Text Key: 288086873
• Report Number: 2029046-2022-00657
• 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,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30673723L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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: SMARTABLATE GENERATOR.
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 82 KG