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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 1012447-12
Device Problems Detachment Of Device Component (1104); Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 03/02/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Evaluation summary: the device was returned for analysis and abbott vascular (av) confirmed the reported separation at the hub. Av reviewed the lot history record and there were no manufacturing nonconformities issued to the reported lot that would have contributed to this event. A review of the complaint history identified no other incidents reported from this lot. Av conducted root cause analysis and determined the issue may be related to a potential product quality issue. The issue is being addressed per internal operating procedures. Av will continue to trend the performance of these devices.
 
Event Description
It was reported that during device preparation of the 2. 5 x 12 mm nc trek dilatation catheter, air was noted in the syringe. It was noted that the device had separated at the hub. The device was not used and there was no patient involvement. A 2. 5 x 12 mm non-abbott dilatation catheter was used 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)
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 Key7355383
MDR Text Key103035881
Report Number2024168-2018-01994
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
Report Date 03/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2020
Device Catalogue Number1012447-12
Device Lot Number71218G2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2017
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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