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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 - SMALL INTRODUCER, CATHETER

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BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL INTRODUCER, CATHETER Back to Search Results
Model Number D138501
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/08/2022
Event Type  malfunction  
Manufacturer Narrative
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. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Manufacturer's reference number: (b)(4).
 
Event Description
It was reported that an unknown patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath - small. The vizigo valve broke before entering the dilator. It was reported that the vizigo¿ sheath was being flushed and began leaking. The vizigo¿ was replaced, and the issue was resolved. The case continued. There was physical damage on valve/hub. The valve broke before entering dilator. The hemostasis valve (gasket)did not break into two or more separate pieces. The hemostatic valve/brim cap/hub did not become detached from the sheath. Air did not enter the patient¿s body; they figured out the problem before. This issue did not require percutaneous or surgical removal. The patient¿s hemodynamics were not compromised due to bleeding. No patient consequences were reported. Hemostatic valve separation is mdr-reportable.
 
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Brand NameCARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL
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
33 technology drive
irvine, CA 92618
646591-798
MDR Report Key15308984
MDR Text Key303395772
Report Number2029046-2022-02020
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016253
UDI-Public10846835016253
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD138501
Device Catalogue NumberD138501
Device Lot Number00002013
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received08/31/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/28/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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