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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT MINI TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012270-15
Device Problems Detachment Of Device Component (1104); Kinked (1339); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/31/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 the procedure was to treat a lesion in the circumflex artery with mild tortuosity and heavy calcification. A 2x15mm mini trek rx balloon dilatation catheter (bdc) was advanced toward the target lesion and failed to cross due to the anatomy. Upon removal the bdc was held up, a kink was noted in the mid shaft and the mid shaft suddenly separated. The device was completely outside the patient anatomy. A same size mini trek was used to continue the procedure. There was no adverse patient effect and no reported clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Visual and dimensional inspections were performed on the returned device. The shaft separation and kink were confirmed. The reported failure to advance could not be replicated in a testing environment as it was based on operational circumstances. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. 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 incidents from this lot. Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
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Brand NameMINI TREK 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 Key6119351
MDR Text Key60756828
Report Number2024168-2016-08222
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeHK
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 12/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue Number1012270-15
Device Lot Number60514G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/17/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2016
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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