• 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 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 TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012274-30
Device Problems Deflation Problem (1149); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2021
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported this was a procedure to treat a pulmonary artery. A trek rx 3x30mm balloon delivery catheter (bdc) was advanced to the target lesion. However, the balloon was unable to deflated after inflating to 8-10 atmospheres. The physician decided to insert contrast medium 50/50 in order to rupture the balloon. Once ruptured, the balloon was attempted to be removed in the guide catheter. However, during removal, it was observed 20cm of the distal part of the balloon separated. Since the distal part was already in the guide catheter, it was easily removed. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key12615622
MDR Text Key276657652
Report Number2024168-2021-09117
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012274-30
Device Catalogue Number1012274-30
Device Lot Number10330G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/12/2021 Patient Sequence Number: 1
-
-