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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VORTX DIAMOND - 18; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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BOSTON SCIENTIFIC CORPORATION VORTX DIAMOND - 18; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 82875
Medical Device Problem Code Contamination (1120)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 12/21/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event or Problem Description
It was reported that the device became unsterile.A 4mm/3.7mm vortx diamond - 18 was selected for use.During preparation, the device became unsterile/filthy because it jumped out and was dropped while the nurse is handing the device to the doctor; device became unusable.There was a tendency that it jumped out when the device was taken out after there is no more mount/pasteboard.The procedure was completed with another of same device.No patient complications reported.
 
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Brand Name
VORTX DIAMOND - 18
Common Device Name
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8249511
Report Number2134265-2018-65094
Device Sequence Number1439970
Product Code KRD
UDI-Device Identifier08714729324881
UDI-Public08714729324881
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K102714
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date06/16/2021
Device Model Number82875
Device Catalogue Number82875
Device Lot Number0022386119
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/21/2018
Initial Report FDA Received Date01/15/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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