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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 1012449-25
Device Problem Detachment Of Device Component (1104)
Patient Problem No Patient Involvement (2645)
Event Date 01/29/2018
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: visual inspection was performed on the returned device. The reported separation was 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 incidents from this lot. The investigation determined the reported difficulty appears to be related to operational context. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that a 3. 0 x 25mm nc trek balloon dilatation catheter was prepped accordingly, however, after prep it was noted that the proximal (shaft) was broken into two pieces at about 10 cm. The device was not used on the patient. Another same size nc trek was used to successfully complete the procedure. There was no clinically significant delay in the procedure and no adverse patient effects. 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)
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 Key7290844
MDR Text Key100916315
Report Number2024168-2018-01330
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648151897
UDI-Public08717648151897
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K110134
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
Report Date 02/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue Number1012449-25
Device Lot Number70810G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2017
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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