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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 1012272-20
Device Problems Detachment Of Device Component (1104); Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 05/10/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Date of occurrence has been estimated. Evaluation summary: visual inspection was performed on the returned device. Returned device analysis noted that the shaft was separated. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Review of the complaint history identified no other similar incidents from this lot. The investigation was unable to determine a conclusive cause for the noted shaft separation. There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
 
Event Description
The trek was returned with a proximal shaft separation. Follow-up with the physician was performed; however, the physician was unaware of the shaft separation and was unable to provide any additional information.
 
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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 Key7603166
MDR Text Key111680040
Report Number2024168-2018-04481
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
Report Date 06/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Catalogue Number1012272-20
Device Lot Number70928G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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