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 SAVION FLX; WIRE, GUIDE, CATHETER
  • 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 SAVION FLX; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 1006
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/14/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the tip of the guidewire broke off inside a patient during a procedure.A savion flx guidewire was selected for a right let arterial case via left wrist access.The patient had tortuous anatomy and while attempting to exchange the guidewire, the tip broke off inside the sheath.The physician was able to snare the wire fragment and complete the procedure.There were no patient complications reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SAVION FLX
Common Device Name
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10139255
Report Number2134265-2020-07783
Device Sequence Number1800649
Product Code DQX
UDI-Device Identifier08714729978824
UDI-Public08714729978824
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K180726
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/10/2020
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 Date12/17/2021
Device Model Number1006
Device Catalogue Number1006
Device Lot Number0024954475
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/15/2020
Initial Report FDA Received Date06/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-