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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 1012272-12
Device Problems Detachment Of Device Component (1104); Kinked (1339); Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/20/2018
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 additional relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion in the non-tortuous, non-calcified, mid right coronary artery (rca). A 2. 50 x 12 mm trek rx balloon dilatation catheter (bdc) met resistance during advancement through the guiding catheter and would not go completely through. The proximal shaft of the bdc kinked and separated approximately 10 cm proximal to the 90 cm marker and the rest of the shaft was still in the guide catheter. An unspecified trapper balloon catheter was advanced into the guide catheter, inflated to trap the separated bdc shaft within the guide catheter and they were removed from the anatomy as a unit. At that point the right radial artery access site was lost. They changed the access site to the left radial artery and used a 2. 5 x 15 mm non-abbott bdc to complete the procedure. Although there was a delay in the procedure, it is not considered to be clinically significant. There was no reported adverse patient sequela. No additional information provided.
 
Manufacturer Narrative
(b)(4) correction- device status changed from returning to not returned. The device was not returned for evaluation. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no other incidents from this lot. The investigation determined the reported kink and separation appear to be related to circumstances of the procedure; however, a conclusive cause could not be determined for the reported difficulty positioning the balloon dilatation catheter. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
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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 Key7335977
MDR Text Key102305450
Report Number2024168-2018-01782
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 06/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Catalogue Number1012272-12
Device Lot Number71115G1
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 Received06/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2017
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: 03/13/2018 Patient Sequence Number: 1
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