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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 1012445-15
Device Problems Detachment Of Device Component (1104); Kinked (1339); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/04/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Evaluation summary: the device was returned. A visual and dimensional inspection was performed on the returned device. The reported kinked shaft and shaft detachment were confirmed. The reported failure to advance could not be tested as it was based on operational circumstances. 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 did not indicate a lot specific quality issue. The investigation determined that the reported difficulties appear to be related to circumstances of the procedure. There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
 
Event Description
It was reported the procedure was performed to treat a lesion in the obtuse marginal vessel with moderate calcification. The 2. 0 x 15 mm nc trek balloon dilatation catheter (bdc) was advanced for dilatation. During advancement of the nc trek, resistance was met with the calcification and the proximal shaft kinked, then separated outside the anatomy. This was prior to reaching the lesion. The nc trek was removed without issue and a non-abbott bdc was used for successful dilatation. A 3. 0 x 8 mm xience alpine stent was successfully deployed to treat the lesion. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
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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)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
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 Key6955472
MDR Text Key90444942
Report Number2024168-2017-08262
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648151651
UDI-Public08717648151651
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
Report Date 10/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Catalogue Number1012445-15
Device Lot Number5072761
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2015
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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