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

Model Number D134801

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

Patient Problem Cardiac Arrest (1762)

Event Date 02/03/2023

Event Type  Death  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.Manufacturer's reference number:(b)(4).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt)¿ ambulatory surgery center (asc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cardiac arrest and ultimately passed away.It was reported that a patient passed away following an ablation procedure.The bwi representative reported that after the patient was patched and before beginning the procedure, the patient went into a ventricular tachycardia (vt) storm.They reported that the patient then went into ventricular fibrillation (v-fib) and they lost their pulse.They reported that the patient was already in vt and was unconscious.They discovered the patient had lost their pulse while taking the patient's pulse on the patient's wrist.The medical intervention provided was cpr and that the patient was brought back.They reported that ablation was then performed and completed.It was also reported that the carto 3 system displayed a chest patch sensor error (error code unknown).They stated that they were unable to take points while mapping.They stated that they tried moving the chest patch cable and straightened them out without resolution.They replaced the chest patch cable with a back patch cable and the issue was resolved.A replacement chest patch cable was requested.Additional information was received.It was reported that the patient entered the room unconscious and in vt.They required cpr after carto patch placement, but before any groin access.Cpr was successful and an impella device was placed.Successful vt ablation was performed.The patient returned to the icu and passed away.The cause of death is recorded as metabolic acidosis due to myocardial injury and tissue hypoperfusion.The physician believes the cause of death to be perforation by a rib during cpr in addition to the patient¿s condition.This event is being conservatively reported under the thermocool® smart touch® sf bi-directional navigation catheter since it cannot be completely disassociated from the event leading to the patient¿s death.The location patch issue is not mdr reportable.This is highly detectable, and the most likely harm is procedure delay or cancellation.

Manufacturer Narrative

Additional information was received on 12-apr-2023.It was reported that the following biosense webster inc.Products used were as follows: thmcl smtch sf bid, tc, d-f.Soundstar eco ge 8f catheter.8.5f sheath with curve viz mdc.Bi dir 7fr def cs,d-f,12 pin.Unk abbott brk needle.Unk boston scientific quad.As such, the d 4.Catalog, d 4.Unique identifier( udi), and g4.Pma/ 510(k) sections were updated, as well as the concomitant product section.It was clarified that the date of event was on 03-feb-2023, and not 02-mar-2023, as previously reported.Therefore, the b 3.Date of event has been updated.The patch cables were placed in the reprocessing bin by mistake by staff, so they did not have the product code until locating them.Their initial attempt to call in was not recorded.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Since no device has been received for analysis, 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).

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16726672
• MDR Text Key: 313156814
• Report Number: 2029046-2023-00798
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2023

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: D134801
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 04/12/2023; 06/30/2023
• Supplement Dates FDA Received: 05/10/2023; 06/30/2023
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; BI DIR 7FR DEF CS,D-F,12 PIN; CARTO 3 SYSTEM; CARTO 3 SYSTEM; IMPELLA DEVICE; IMPELLA DEVICE; SOUNDSTAR ECO GE 8F CATHETER; UNK ABBOTT BRK NEEDLE; UNK BOSTON SCIENTIFIC QUAD; YELLOW PATCH SENSOR CABLE KIT; YELLOW PATCH SENSOR CABLE KIT
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 68 YR
• Patient Sex: Male