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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 1012451-15
Device Problems Inflation Problem (1310); Difficult To Position (1467); Difficult to Remove (1528); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/15/2017
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 was not returned for analysis. The complaint investigation determined the reported difficulty was related to manufacturing issues associated with the protective sheath. 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. Abbott vascular communicated the voluntary field action to the fda on march 17, 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.
 
Event Description
It was reported that the procedure was to treat a lesion located in the 80% stenosed mid to distal right coronary artery. The guide wire crossed successfully followed by advancement of a 3. 5 x 15 trek balloon catheter which was used for pre-dilatation of the mid to distal rca, respectively. A 4. 0 x 18 mm xience prox stent was deployed. Post-dilatation was attempted with the a 3. 5 x 15 mm nc trek; however, resistance was felt during advancement of the balloon catheter to the deployed stent and upon attempted inflation of the balloon it would not inflate. It was stated that there was some resistance felt during removal of the protective sheath prior to use of the nc trek balloon catheter in the patient and it was difficult to load the balloon catheter onto the guide wire. A new 3. 5 x 15 mm nc trek was used for post dilatation with a very good result. No adverse patient effects or clinically significant delay in the procedure were reported. No additional information was provided.
 
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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 Key6599901
MDR Text Key76386938
Report Number2024168-2017-04604
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeTH
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
Report Date 05/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue Number1012451-15
Device Lot Number60801G1
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 Received05/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2037-2039-2017

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