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U.S. Department of Health and Human Services

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

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BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER Back to Search Results
Model Number D138502
Device Problems Backflow (1064); Patient Device Interaction Problem (4001)
Patient Problems Air Embolism (1697); Cardiac Arrest (1762)
Event Date 08/04/2022
Event Type  Injury  
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 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. Manufacturer's reference number: (b)(4).
 
Event Description
It was reported that a male patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ medium. There was air in the sheath and the patient suffered an air embolism which caused ventricular fibrillation (cardiac arrest) requiring defibrillation. Air in the carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ medium was observed by the examiner. The map catheter system (smart touch sf). While smart touch sf was inserted in the carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ medium before ablation. Ventricular fibrillation developed as a result of air embolism. Continuous sheath-irrigation was done during entire procedure. The patient was in normal sinus rhythm at the end of procedure. The procedure was successfully completed. Additional information was received. The physician removed the carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ medium and the smart touch sf from the patient and flushing/ irrigation the carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ medium, pentaray and smart touch sf again. The ventricular fibrillation required defibrillation. The patient has not exhibited any neurological symptoms since the procedure was completed. The adverse event was discovered during use of biosense webster products. The physician¿s opinion on the cause of this adverse event was a biosense webster, inc. Product malfunction. The patient outcome of the adverse event was fully recovered (no residual effects). It is unknown if the patient required extended hospitalization because of the adverse event. The smart touch sf catheter did not have a sensor error. There was no malfunction reported on either the generator or the pump. 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. The air in the sheath was assessed as a mdr reportable malfunction. The potential for air embolism as the air in the side port tubing has the potential to mobilize resulting in an increased risk to the patient.
 
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Brand NameCARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM
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 Key15308438
MDR Text Key298773181
Report Number2029046-2022-02011
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016277
UDI-Public10846835016277
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K170997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD138502
Device Catalogue NumberD138502
Device Lot Number50000126
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/29/2022 Patient Sequence Number: 1
Treatment
PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE GENERATOR KIT-WW; SMARTABLATE PUMP KIT-WW; THMCL SMTCH SF UNID, TC, F
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