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 PT; 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 PT; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 2779
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/30/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment occurred.The stenosed target lesion was located in the mildly tortuous and mildly calcified knee vascular.A 185cm pt2 guidewire was used for delivery.However, during procedure, it was noted that the guidewire was completely detached 5 centimeters from the tip.The device was removed by snaring.The procedure was completed with a different device.There were no patient complications nor injuries reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PT
Common Device Name
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12045735
Report Number2134265-2021-07618
Device Sequence Number897793
Product Code DQX
UDI-Device Identifier08714729471189
UDI-Public08714729471189
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K030617
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/22/2021
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 Date01/15/2022
Device Model Number2779
Device Catalogue Number2779
Device Lot Number0025057077
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/31/2021
Initial Report FDA Received Date06/22/2021
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;
Patient Age78 YR
-
-