• 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 1012449-20
Device Problems Detachment Of Device Component (1104); Kinked (1339); Stretched (1601)
Patient Problem No Patient Involvement (2645)
Event Date 02/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Evaluation summary: visual inspection was performed on the returned device which identified an inner member separation at the proximal end of the proximal marker and outer member stretching at the proximal seal. The reported kink was confirmed. A review of the lot history record identified one manufacturing nonconformity issued to the reported lot that would have contributed to this event. A review of the complaint history identified other similar incidents from this lot. The complaint investigation determined the noted outer member stretching was determined to be related to manufacturing issues associated with the protective sheath. The investigation determined the reported kink appears to be related to operational context. The issue is being addressed per internal operating procedures. Abbott vascular will continue to trend the performance of these devices.
 
Event Description
It was reported that during unpacking of a 3. 0 x 20 mm nc trek balloon catheter, it was noted that the proximal shaft near the marker was kinked. The device was not used. Another nc trek was successfully used to complete the procedure. There was no clinically significant delay in procedure and no adverse patient effects. No additional information was provided. Device analysis identified an inner member separation at the proximal end of the proximal marker and outer member stretching at the proximal seal.
 
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 Key7535700
MDR Text Key109009213
Report Number2024168-2018-03830
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeLE
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
Report Date 05/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Catalogue Number1012449-20
Device Lot Number60126G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-