• 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 NC TREK CORONARY DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, 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
 

ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Lot Number 10118G1
Device Problems Activation, Positioning or SeparationProblem (2906); Failure to Deflate (4060)
Patient Problem Myocardial Infarction (1969)
Event Date 06/24/2021
Event Type  Injury  
Event Description
Patient had lhc and lesion noted in rca, stent with xience sierra 3. 25 x 33 was placed and post dilate w/balloon nc trek 3. 5 x 15mm on second inflation balloon would not deflate repeat aspirations and blood return from line. Pt with st elevation and balloon removed- balloon not present from line. Decreased flow noted in proximal rca, multiple attempts with snare unsuccessful. Patient transferred to hlc with catheter in place right radial for direct surgery. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNC TREK CORONARY DILATATION CATHETER
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
ABBOTT VASCULAR
MDR Report Key12108301
MDR Text Key260143682
Report NumberMW5102265
Device Sequence Number1
Product Code LOX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number10118G1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/01/2021 Patient Sequence Number: 1
-
-