• 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 1012451-12
Device Problems Partial Blockage (1065); Deflation Problem (1149); Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/07/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). Incorrect prep; failure to submerge balloon to activate coating. The device was received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that during a procedure of the non-tortuous, non-calcified, unspecified vessel the nc trek balloon initially failed to inflate. Eventually the balloon was inflated; however, the balloon could not be deflated for about 60 seconds then was successfully deflated and removed from the anatomy. A blockage in the lumen was suspected. 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). The device returned for analysis. The complaint investigation determined the reported difficulty was related to manufacturing issues associated with the protective sheath. On (b)(6) 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. Abbott vascular performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis. The root cause identification was complicated by the fact that users were describing multiple symptoms when reporting the complaints. To date, the frequency of worldwide reported events for difficulties removing the protective balloon sheath, inflation and deflation has reached an actionable limit, thus abbott vascular communicated the voluntary field action to the fda on (b)(6) 2017 [medwatch # 2024168-2017-02310]. Corrective action has been implemented per site operating procedures. The product will continue to be trended. The abbott internal recall number is 2024168-3/14/2017-002-r.
 
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 Key6077225
MDR Text Key59456546
Report Number2024168-2016-07558
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCA
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 Recall
Type of Report Initial,Followup
Report Date 04/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Catalogue Number1012451-12
Device Lot Number60629G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/28/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
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: 11/03/2016 Patient Sequence Number: 1
Treatment
INFLATION: INDEFLATOR
-
-