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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 1012448-08
Device Problems Break (1069); Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/10/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Date of occurrence is estimated. 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 the 2. 75 x 8 mm nc trek dilatation was noted to be kinked. There was no adverse patient effect reported and no clinically significant delay. No additional information was provided. Returned device analysis noted that the inner member was separated at the proximal balloon marker, but the outer member remained intact. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: the device was returned for analysis and abbott vascular identified that the proximal seal was stretched and the inner member had a separation at the proximal balloon marker. It is likely that the account perceived the stretched proximal seal/inner member separation as the kink. The analysis of the returned device suggests that the stretching/separation may be related to tensile overload when removing the protective sheath. Based on an expanded investigation and further review of the complaint handling database and other sources of nonconformity data, it was determined that the devices performance with regard to the difficulty removing the protective sheath appear to be related to normal variation found in manufacturing. There was no indication of a product quality issue. The performance of these devices will continue to be monitored.
 
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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 Key6368500
MDR Text Key69018932
Report Number2024168-2017-01666
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2018
Device Catalogue Number1012448-08
Device Lot Number50416G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/19/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2015
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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