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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT MINI TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012270-15
Device Problems Difficult To Position (1467); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/09/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The versaturn guide wire referenced is filed under a separate medwatch report number. 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 the procedure was performed to treat a chronic total occlusion [cto] lesion in the mildly calcified left anterior descending coronary artery. A versaturn guide wire was used to switch out a non-abbott cto guide wire after crossing the lesion through a micro-catheter. Pre-dilatation was performed with a small non-abbott balloon catheter. The 2. 0x15 mm mini-trek was loaded on to the versaturn guide wire, but a lot of resistance was met during loading. Resistance was met during removal of the mini trek from the versaturn guide wire; therefore, the mini trek and the versaturn guide wire were removed together as a unit. Outside the anatomy, the mini trek was able to be removed from the versaturn. A new guide wire was used with a non-abbott balloon to complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. There was no additional information provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual and functional inspections were performed on the returned device. The reported difficulty positioning the balloon dilatation catheter over the guide wire was confirmed. The reported difficulty removing the device from the guide wire could not be replicated in a testing environment due to the condition of the returned device. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Review of the complaint history identified no other similar incidents from this lot. The investigation was unable to determine a conclusive cause for the reported difficulties. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Event Description
Subsequent to the previously filed report, additional information was received indicating that after the mini trek was removed from the patient anatomy, the physician attempted to inflate the mini trek together with the guide wire to test if there was an issue with inflation. The mini trek was not inflated in the anatomy. There was no additional information provided.
 
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Brand NameMINI 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 Key7560799
MDR Text Key109890038
Report Number2024168-2018-04051
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Catalogue Number1012270-15
Device Lot Number80215G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2018
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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