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 LUGE; 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 LUGE; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 2749
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 04/05/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that guide wire tip detachment occurred.The target lesion was located in the right coronary artery.A balloon wedge 5fr catheter was selected for use.However, the device was unable to be advanced in the left brachial vein.A 300cm j luge guidewire was used to help the balloon to cross a narrowing in the arm.As the wire was advanced, it was noted that the wire bent up on itself a little and when the wire was slowly removed, it appeared as if the radio-opaque tip had fallen off.A snare was used to extract the broken piece of the wire from the arm.No patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LUGE
Common Device Name
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8549928
Report Number2134265-2019-04334
Device Sequence Number1743653
Product Code DQX
UDI-Device Identifier08714729252214
UDI-Public08714729252214
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K143587
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) 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date01/31/2021
Device Model Number2749
Device Catalogue Number2749
Device Lot Number0023284411
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/05/2019
Initial Report FDA Received Date04/25/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
-
-