• 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 1012452-12
Device Problem Detachment Of Device Component (1104)
Patient Problems Occlusion (1984); Foreign Body In Patient (2687)
Event Date 02/28/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device has not yet been received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a heavily calcified distal circumflex artery. Pre-dilatation was performed with a 2. 5 x 12 mm trek and a 3. 0 x 18 mm xience alpine stent was deployed at 18 atmospheres. Post dilatation was performed with a 3. 0 x 12 nc trek to 20 atmospheres, then a 3. 5 x 12 mm nc trek at 20 atmospheres. A 3. 75 x 12 mm nc trek was also inflated to 20 atmospheres. When removed from the anatomy the tip was separated. There were several attempts with numerous guide wires to retrieve the tip, which took approximately two hours; however, the tip could not be removed and remains in the anatomy and the distal vessel is closed off. The procedure was completed at this time. There was a clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was not returned. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. On march 14, 2017, abbott vascular decided to initiate a voluntary field action for some sizes and lots of the nc trek family of dilatation catheters for difficulty to remove sheath which may lead to inflation or deflation issues. [medwatch # 2024168-2017-02310].
 
Manufacturer Narrative
(b)(4). The device was not returned for evaluation. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no other similar incidents from this lot reported for tip separation. The reported patient effect of occlusion, as listed in the coronary dilatation catheter, nc trek rx, global, instructions for use is a known patient effect that may be associated with use of a coronary catheter in native coronary arteries. It should be noted coronary dilatation catheters (cdc), nc trek rx, global, instructions for use states: balloon pressure should not exceed the rated burst pressure (rbp). The rbp for the nc trek is 18 atms. The investigation determined the reported tip separation, occlusion, and foreign body in patient appear to be related to circumstances of the procedure. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
 
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 Key6433183
MDR Text Key70857312
Report Number2024168-2017-02509
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 Recall
Type of Report Initial,Followup,Followup
Report Date 04/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Catalogue Number1012452-12
Device Lot Number60909G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2016
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: 03/24/2017 Patient Sequence Number: 1
-
-