• 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 RUBICON 18 CATHETER, PERCUTANEOUS

  • 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 RUBICON 18 CATHETER, PERCUTANEOUS Back to Search Results
Model Number 39540
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/04/2020
Event Type  Malfunction  
Event Description

It was reported that the device was contaminated. The target lesion was located in the superficial femoral artery. A 150cm rubicon 18 was selected for use. During unpacking, it was noted that the bottom of the package was not sealed and the device became contaminated. The procedure was completed with another of same device. No patient complications were reported and patient was stable post procedure.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRUBICON 18
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10443366
MDR Text Key204050563
Report Number2134265-2020-11536
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK122394
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/01/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number39540
Device Catalogue Number39540
Device LOT Number0024779969
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/31/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/16/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-