• 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 1012276-15
Device Problems Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2022
Event Type  malfunction  
Event Description
It was reported that the procedure was to treat a mildly tortuous, 60% stenosed lesion in the left anterior descending (lad) artery. An unspecified stent was implanted and a 3. 5x15mm trek rx balloon dilatation catheter (bdc) was advanced and used for post-dilatation without issue. The balloon was inflated 2 times to 10 atmospheres (atm). During deflation of the trek balloon, the physician believed that it took too long to deflate the balloon, however it did fully deflate, and it is unknown how long negative was held for during deflation. There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
The device was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
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 Key13694616
MDR Text Key287671681
Report Number2024168-2022-02344
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648138577
UDI-Public08717648138577
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012276-15
Device Catalogue Number1012276-15
Device Lot Number00604G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-