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U.S. Department of Health and Human Services

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

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BIOSENSE WEBSTER INC UNK_CARTO VIZIGO SHEATH INTRODUCER, CATHETER Back to Search Results
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).
 
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Brand NameUNK_CARTO VIZIGO SHEATH
Type of DeviceINTRODUCER, 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 Key14446507
MDR Text Key292163687
Report Number2029046-2022-01069
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
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 Received05/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_CARTO VIZIGO SHEATH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/31/2022
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/19/2022 Patient Sequence Number: 1
Treatment
CARTO 3 SYSTEM; SMARTABLATE PUMP; UNK TRANSSEPTAL NEEDLE
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