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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT MINI TREK II OTW CORONARY DILATATION CATHETER

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AV-TEMECULA-CT MINI TREK II OTW CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012402-15A
Device Problems Difficult To Position (1467); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/15/2015
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 received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that a non-abbott guide wire advanced into an unspecified coronary artery lesion without issue. Following, a mini trek balloon catheter attempted to advance; however, a "tracking" resistance was felt with the guide wire. The mini trek dilatation catheter was removed with that same "tracking" resistance. Another non-abbott guide wire advanced to that same lesion. The same mini trek attempted to advance over another non-abbott guide wire. Resistance was met at the mini trek balloon site right after insertion. The mini trek was removed and a non-abbott balloon catheter was used successfully. There were no adverse patient effects and there was no clinically significant delay. There was no additional information provided.
 
Manufacturer Narrative
(b)(4). The device was returned for evaluation. The reported difficulties were not confirmed. Based on visual, dimensional and functional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling. The investigation was unable to determine a conclusive cause for the reported difficulties. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other incidents from this lot. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
Subsequent to the initial 30-day medwatch report, the following information was received: a balance middle weight (bmw) guidewire attempted to advance the same mini trek dilatation catheter and resistance was noted. There was no resistance removing the bmw from the mini trek. There were no adverse patient effects. There was no additional information provided.
 
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Brand NameMINI TREK II OTW 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 Key5352077
MDR Text Key35303783
Report Number2024168-2016-00066
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2016
Device Catalogue Number1012402-15A
Device Lot Number31105G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/22/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2013
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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