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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER

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AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012406-20
Device Problems Loose or Intermittent Connection (1371); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/22/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). The customer reported the device was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that a percutaneous coronary intervention was performed in the distal right coronary artery (rca), thrombotic lesion. Prior to trek dilatation catheter insertion, the flush port un-twisted from the syringe portion of the treks hub. Reportedly, the syringe was difficult to connect to the trek's hub as it would untwist from the syringe. The same trek device was used, and the flush port held as the rca lesion was dilated up to 14 atms without further issues. Following, the trek was difficult to remove from the balance middle weight (bmw) guide wire as it was reportedly tight. The trek was removed and the procedure was completed with the same bmw guide wire without further issues. Stents were implanted without further issues. There were no adverse patient effects reported. No additional information was provided regarding this issue.
 
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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 Key8532159
MDR Text Key142513470
Report Number2024168-2019-03113
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 04/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Catalogue Number1012406-20
Device Lot Number80306G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2018
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: 04/19/2019 Patient Sequence Number: 1
Treatment
BALANCE MIDDLE WEIGHT GUIDE WIRE
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