MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM; INTRODUCER, CATHETER

Model Number D138502

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Ischemic Heart Disease (2493)

Event Date 10/13/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and suffered st segment elevation and cardiac arrest which required surgical intervention.During a clinical trial (adagio medical) the patient had immediate st elevation and the heart stopped beating.It was confirmed by echo and intracardiac echocardiography (ice).Cpr, extracorporeal membrane oxygenation (ecmo) and impella were performed as medical intervention.It is unknown at the time of reporting if the patient was in stable condition.There was no ablation data on the electrophysiology (ep) recording system.The procedure was completed with the carto ablation data.

Manufacturer Narrative

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

On 8-nov-2021, additional information was received.It was reported that the patient¿s gender is male.Therefore, a3.Gender has been updated.It was also reported that a smartablate generator kit-us was used during the procedure.Therefore, the concomitant product section has been updated.The physician¿s name is dr.(b)(6).The contact number and email address are unknown.The e 1.Initial reporter title, e 1.Initial reporter first name, e 1.Initial reporter last name, e3.Initial reporter occupation, and e2.Health professional have been updated.It was also reported that this adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is unknown.Intervention provided was an ecmo (extracorporeal membrane oxygenation).The patient outcome of the adverse event is unknown, as well as whether the patient required extended hospitalization because of the adverse event.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) was performed for the finished device 50000012 number, and no internal action related to the complaint was found during the review.Based on the mre, h4.Device manufacture date has been updated.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: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irvine CA 92618
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12765790
• MDR Text Key: 280449951
• Report Number: 2029046-2021-01907
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2021

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 Expiration Date: 08/17/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 12/05/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2021
• 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 KIT-US.; UNK_CARTO 3.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male