Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VORTX DIAMOND - 18; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION VORTX DIAMOND - 18; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 82875
Device Problem Contamination (1120)
Patient Problem No Patient Involvement (2645)
Event Date 11/19/2019
Event Type  malfunction  
Event Description
It was reported that sterility was compromised.A vortx diamond-18 device was selected for an embolization procedure.As the device was being removed from the inner packaging, the pusher jumped out of the packaging.The sterility was compromised.Another of the same device was used to complete the procedure.No adverse effects to the patient were reported and the patient was stable post procedure.
 
Event Description
It was reported that sterility was compromised.A vortx diamond-18 device was selected for an embolization procedure.As the device was being removed from the inner packaging, the pusher jumped out of the packaging.The sterility was compromised.Another of the same device was used to complete the procedure.No adverse effects to the patient were reported and the patient was stable post procedure.
 
Manufacturer Narrative
Device analysis by mfr: visual inspection of the returned device showed that the main coil was returned inside the coil introducer.The plunger and retaining clip were also returned.The coil introducer was inspected and no anomalies were noted.The coil was inspected and not abnormalities were found.No damages were found in the device.Functional inspection showed that the coil was able to be advanced through the coil introducer without problem.No resistance was felt.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VORTX DIAMOND - 18
Type of Device
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9416790
MDR Text Key175667735
Report Number2134265-2019-14960
Device Sequence Number1
Product Code KRD
UDI-Device Identifier08714729324898
UDI-Public08714729324898
Combination Product (y/n)N
PMA/PMN Number
K102714
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/17/2021
Device Model Number82875
Device Catalogue Number82875
Device Lot Number0022811033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2019
Date Manufacturer Received01/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-