• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT 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
 

AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012272-15
Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/18/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that during the procedure to treat a chronic total occlusion, the 2. 5 x 15 mm trek dilatation catheter was advanced, without a guide wire, to use as a trapping balloon. The trek was advanced next to a guide wire, in which a non-abbott microcatheter was advanced over. The trek dilatation catheter was advanced quickly, with long passes. There was no interaction between the devices; however, as the trek dilatation catheter was advanced, it separated at the hypotube, during advancement through the rotating hemostatic valve, at a location outside the patient anatomy. The separated segments were easily removed from the patient anatomy and there was no adverse patient effect. There was no clinically significant delay. No additional information was provided.
 
Manufacturer Narrative
(b)(4). A visual inspection was performed and the reported shaft separation was confirmed. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents reported from this lot. It should be noted that the cdc, trek rx instructions for use (ifu) states: the trek rx coronary dilatation catheters are indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion. Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction. Balloon dilatation of a stent after implantation. The investigation determined the reported shaft separation appears to be related to circumstances of the procedure. Based on the reported information, it is likely that manipulation during advancement through the rotating hemostatic valve likely kinked the device resulting in the shaft separation. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
EL COYOL, COSTA RICA REG# 3009031392
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key7592017
MDR Text Key110846947
Report Number2024168-2018-04397
Device Sequence Number1
Product Code LOX
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 company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Catalogue Number1012272-15
Device Lot Number80219G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-