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); Myocardial Infarction (1969)

Event Date 06/07/2022

Event Type  Death  

Event Description

It was reported that a 58-year-old patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a st elevation, myocardial infarction, cardiac arrest, and ultimately death.It was reported that while performing a pvc ablation, following transeptal puncture and during mapping in the left ventricle (lv) st elevations were observed.Interventional cardiologist was called to perform right heart catheterization.Right coronary artery (rca) appeared completely blocked.Patient went into vt/vfib, the patient coded.The clinical account specialist stated that they left the room at this time.Multiple cardioversions were performed in addition to cpr.Impella devices were placed in patients lv and rv.The patient was stabilized and left the ep lab.Patient was brought to icu where death occurred.The catheters were discarded and not available for return.The caller did not have the lot information for the catheters at the time of the call.The bwi catheters in the patient's body at the time of the event were an ultrasound soundstar catheter and an stsf ablation catheter.The physician¿s opinion on the cause of this adverse event is that it was related to the procedure and/or patient condition.Medical intervention provided was right heart cath, cpr, and impella.The patient outcome of this adverse event was death.Other relevant history includes previous cabg procedure.No ablation performed.The date of death is (b)(6) 2022.In physician¿s opinion, the cause of death was a stemi.All deaths were bwi fda approved: ce mark devices are involved are reportable.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.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).

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14844304
• MDR Text Key: 294873874
• Report Number: 2029046-2022-01453
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• 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: 06/07/2022
• 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: IMPELLA DEVICES; SOUNDSTAR CATHETER; UNSPECIFIED TRANSSEPTAL NEEDLE
• Patient Outcome(s): Life Threatening; Death
• Patient Age: 58 YR
• Patient Sex: Male