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: ABBOTT VASCULAR ABBOTT VASCULAR; TREK CORONARY DILATATION 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
 

ABBOTT VASCULAR ABBOTT VASCULAR; TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012274-20
Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/04/2019
Event Type  Injury  
Event Description
Cath lab pt for attempted balloon dilation of lesion.Upon attempting to withdraw deflated balloon, a fragment of the balloon sheared off from the device.Unable to retrieve in cath lab.Fragment retrieved during cagb procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ABBOTT VASCULAR
Type of Device
TREK CORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
3200 lakeside dr.
santa clara CA 95054
MDR Report Key9404828
MDR Text Key169030067
Report Number9404828
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2022
Device Model Number1012274-20
Device Catalogue Number1012274-20
Device Lot Number90719G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/15/2019
Distributor Facility Aware Date11/04/2019
Event Location Hospital
Date Report to Manufacturer11/15/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
Patient Weight66
-
-