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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 1012449-12
Device Problem Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2016
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 is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion located in the mid left anterior descending (lad) artery with heavy tortuosity and mild calcification. Resistance was not felt during advancement of the 3. 0 x 12mm nc trek rx balloon dilatation catheter (bdc) to the lesion and it crossed successfully; however it failed to inflate. A replacement bdc was used to complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure reported. No additional information was provided.
 
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 did not indicate a lot specific quality issue. The investigation was unable to determine a conclusive cause for the reported inflation issue. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Manufacturer Narrative
(b)(4). Corrections: the device was reported as not returning; however, it was returned for analysis. Results code and conclusions code were removed. Evaluation summary: visual and functional inspections were performed on the returned device. The reported failure to inflate was confirmed. The investigation was unable to determine a conclusive cause for the reported inflation issue. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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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 Key6193079
MDR Text Key63328437
Report Number2024168-2016-09095
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,Followup
Report Date 04/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Catalogue Number1012449-12
Device Lot Number50826G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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