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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 Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2021
Event Type  malfunction  
Manufacturer Narrative
The product investigation was completed. Device evaluation details: visual analysis of the returned sample revealed that the hemostatic valve was found dislodged inside of the hub of the vizigo sheath. Also, the brim cap and silicone ring were found in normal condition. The vessel dilator was not returned and the vizigo shaft was inspected, and it was found in normal condition. Microscopic examination on the hemostatic valve surface showed evidence of stress marks on the outer diameter. On the other hand, the brim cap and the silicone ring were placed in the correct position and found in good conditions. Due to the conditions of the hemostatic valve, an internal action was opened. It should be noted that product failure is multifactorial. Based on the information currently available, a microscopic examination of the returned product indicates that the hemostatic valve was found dislodged into the hub. It was determined that the issue observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve, the stress marks, and physical damage observed which suggest that excessive force was applied. According to the odp (optimal performance guide), there are some precautions on inserting the dilator into the vizigo sheath: ¿always insert a dilator straight into the center of the sheath¿s valve to prevent damage to the valve. Do not insert a dilator at an angle, as damage to the sheath valve may occur. ¿ a device history record review was performed for the finished device 00001797 number, and no internal actions related to the complaint were found during the review. 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
A patient underwent an ablation procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath small analysis of the returned sample revealed that the hemostatic valve was found dislodged inside of the hub of the vizigo sheath. The finding was identified on (b)(6) 2022. It was initially reported by the customer that during the procedure, the catheter couldn¿t advance in the introducer due to the impediment. The second catheter was used to complete the operation. There was no report on adverse event on patient. 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
31 technology dr
irvine, CA 92618
6465917981
MDR Report Key14103832
MDR Text Key289199421
Report Number2029046-2022-00792
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016253
UDI-Public10846835016253
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K170997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/21/2022
Device Model NumberD138501
Device Catalogue NumberD138501
Device Lot Number00001797
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2022
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2021
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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