• 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 RX 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 RX CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012274-20
Device Problems Entrapment of Device (1212); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984)
Event Date 10/07/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a left anterior descending artery. Pre-dilatation was performed with a 3. 0x20 trek balloon dilatation catheter. Three inflations were performed at 16 atmospheres (atm), 18 atm and 22atm. At the third inflation at 22atm, the balloon burst, got caught within a vessel and part of the balloon remained in the anatomy. A micro catheter, second unspecified wire were placed and an unknown drug-eluting stent was used to embed the separated balloon portion to the vessel wall. The account noted that there was a clinically significant delay which caused an occlusion due to the trek balloon. The occlusion was treated with three other balloons and drug-eluting stents to successfully complete the procedure successfully. There was no patient sequela. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTREK RX 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 Key9261144
MDR Text Key164668491
Report Number2024168-2019-13082
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648138447
UDI-Public08717648138447
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Model Number1012274-20
Device Catalogue Number1012274-20
Device Lot Number90325G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/25/2019
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: 10/31/2019 Patient Sequence Number: 1
-
-