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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 1012272-15
Device Problems Difficult to Remove (1528); Material Separation (1562)
Patient Problems Angina (1710); Ischemia (1942)
Event Date 11/22/2018
Event Type  Injury  
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. The nc trek referenced is being filed under a separate medwatch report.
 
Event Description
It was reported that the procedure was to treat a de novo lesion in a mildly calcified distal right coronary artery that was 90% stenosed. Pre-dilatation was performed with a 2. 5 x 15 mm trek balloon catheter. However, the device met resistance during removal and the patient felt pain and had timi ii flow. Therefore, an attempt was made to advance a 2. 5 x 15 mm nc trek balloon catheter for pre-dilatation; however, the device met resistance with a guide wire during advancement. When the device was inspected, it was noted that a part of the balloon had separated inside the anatomy. Therefore, an aspiration catheter was used to remove the balloon. The procedure was then aborted and the patient was scheduled for another procedure with rotablation. There was a clinically significant delay in the procedure. No additional information was provided.
 
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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 Key8160751
MDR Text Key130226281
Report Number2024168-2018-09642
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Catalogue Number1012272-15
Device Lot Number80929G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2018
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: 12/13/2018 Patient Sequence Number: 1
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