MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_CARTO VIZIGO SHEATH; INTRODUCER, CATHETER

Catalog Number UNK_CARTO VIZIGO SHEATH

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Ischemic Heart Disease (2493)

Event Date 04/26/2022

Event Type  Injury  

Event Description

It was reported that a male patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and an unknown carto vizigo sheath.The patient suffered st elevation, cardiac arrest, air embolism and a cardiac catheterization.During an afib procedure after going transeptal, the patient's pressure dropped.Then st elevation was noted and that bubbles were visualized in the aortic valve on the intracardiac echo (ice) image.The patient was in cardiac arrest and cpr was performed.The cause of the bubbles is unknown.The patient was stable at the time of the call.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was the physician was unsure as the products appeared to be functioning properly.Cpr was performed for a few minutes, followed by a cardiac catheterization procedure performed by another interventional cardiologist.The patient outcome of the adverse event was fully recovered (no residual effects).The patient stayed overnight for monitoring.Patient fully recovered with no neurological symptoms.Ablation catheter information is not available because the ablation catheter was not in body at time of event.There was no malfunction that was observed with the pentaray.No catheter was hooked to the pump at time of event.The pentaray and vizigo sheath will be reportable based on the available information.The sheath and /or pentaray could have introduced the air.The pentaray catheter will be returned for irrigation analysis.This report is for the vizigo sheath.The pentaray has been reported in manufacturer report number 2029046-2022-01068.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

Since no device has been received for analysis, 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.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).

Manufacturer Narrative

On 31-may-2022, bwi received additional information regarding the event.The vizigo lot number and catheter are not available.The smartablate pump serial number is g4cp-1065.No service is being requested at this time.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: UNK_CARTO VIZIGO SHEATH
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14446507
• MDR Text Key: 292163687
• Report Number: 2029046-2022-01069
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_CARTO VIZIGO SHEATH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; SMARTABLATE PUMP; UNK TRANSSEPTAL NEEDLE
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male