• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012449-12
Device Problems Detachment Of Device Component (1104); Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/12/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (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 evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the 3. 0x12 nc trek met no resistance advancing into the 6 french guide catheter, but the shaft of the nc trek separated and kinked. The shaft separated in the guide catheter and was removed with the guide catheter. A shorter, 3. 0x8 nc trek was used to complete the procedure with a larger guide catheter. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual inspection was performed on the returned device. The reported proximal shaft separation and kink were confirmed. The investigation determined the reported proximal shaft separation and kink appear to be related to circumstances of the procedure. 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 of the reported lot did not indicate a lot specific quality issue related to proximal shaft separation or a kink. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
 
Event Description
Additional information: the device was not prepped (air aspiration) prior to use.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6393436
MDR Text Key69814539
Report Number2024168-2017-01968
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
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 05/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue Number1012449-12
Device Lot Number60511G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/09/2017 Patient Sequence Number: 1
Treatment
CORDIS 6F AL 1
-
-