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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 Material Separation (1562); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2021
Event Type  malfunction  
Event Description
A patient underwent an ablation procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath - medium for which biosense webster¿s product analysis lab identified that the hemostatic valve was not on the device. A guide wire was inserted through the sheath and the valve was not found within the vizigo. During the procedure, it was reported that the dilator was not able to go through the sheath. The sheath was replaced and the issue resolved. No patient consequences were reported. The sheath obstruction is not mdr-reportable. Hemostatic valve separation is mdr-reportable.
 
Manufacturer Narrative
The product investigation was completed. Device evaluation details: visual analysis of the returned sample revealed the hemostatic was not on the device. For this reason, a guide wire was inserted through the sheath and the valve was not found inside the vizigo. Microscopic evaluation of the brim cap and the silicone ring revealed they were placed in the correct position and found in good conditions. A device history record was performed for the finished device 50000032 lot number, and no internal actions related to the complaint were found during the review. The issue reported by the customer was confirmed. It should be noted that product failure is multifactorial. 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. " 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 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
gabriel alfageme
31 technology dr
irvine, CA 92618
9497898687
MDR Report Key13574969
MDR Text Key290786967
Report Number2029046-2022-00327
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016277
UDI-Public10846835016277
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 Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/07/2022
Device Model NumberD138502
Device Catalogue NumberD138502
Device Lot Number50000032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2021
Date Manufacturer Received01/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2021
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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