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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 1012450-15
Device Problems Difficult To Position (1467); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/29/2016
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 is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that during device preparation and prior to use, the protective sheath was difficult to remove. After the device was prepared, resistance was met while advancing the device on the guide wire. The device was removed from the wire and a different device was used in the procedure without reported issue. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: the device was returned for analysis and although the protective sheath was not returned, abbott vascular (av) identified stretching near the proximal balloon seal, which is indicative of the reported difficulty removing the protective sheath. The device was successfully advanced over a proxy guide wire. Based on an expanded investigation and further review of the complaint handling database and other sources of nonconformity data, it was determined that the device performance with regards to the difficulty with 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 Key6048152
MDR Text Key58137065
Report Number2024168-2016-07186
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFR
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,Followup
Report Date 04/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2018
Device Catalogue Number1012450-15
Device Lot Number51031G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2015
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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