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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 1012453-08
Device Problems Detachment Of Device Component (1104); Kinked (1339)
Patient Problem No Patient Involvement (2645)
Event Date 01/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was returned for analysis and abbott vascular (av) identified a 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 before use, the hub and proximal shaft of a 4. 0 x 8 mm nc trek balloon dilatation catheter (bdc) were noted to be kinked. Therefore, the bdc was replaced with another unspecified device to successfully complete the procedure. There was no patient involvement. There was no clinically significant delay in the procedure and no adverse patient effects. Returned device analysis revealed that the hypotube separated from the device. 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 Key7336160
MDR Text Key102344994
Report Number2024168-2018-01786
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 03/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Catalogue Number1012453-08
Device Lot Number70524G2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2017
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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