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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012449-20
Device Problems Detachment Of Device Component (1104); Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/09/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that during a procedure of the right coronary artery (rca), the device was being inserted over the guide wire with forceful pushing and the proximal shaft was kinked and then separated. There was no reported adverse patient effect. The device was removed and a different balloon catheter used in the procedure. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual and inspection was performed on the returned device. The kink and shaft separation were confirmed. 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 similar incidents from this lot. The investigation determined the reported difficulties appear to be related to operational context. 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 NameNC 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 Key5974013
MDR Text Key55890551
Report Number2024168-2016-06339
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110134
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 10/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue Number1012449-20
Device Lot Number60519G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2016
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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