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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 1012268-06
Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/23/2016
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). The device was not returned for analysis. It should be noted that the preparation for use section of the mini trek rx coronary dilatation catheter instructions for use specifies: all air must be removed from the balloon and displaced with contrast prior to inserting into the body; otherwise, complications may occur. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. 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. Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was performed to treat a 99% stenosed lesion in the mid left anterior descending artery, with mild tortuosity and heavy calcification. The 1. 2 x 6 mm mini trek balloon catheter prepared for use in the anatomy. The mini trek was advanced, but resistance was noted with the calcification, and the mini trek could not cross the lesion. The balloon was inflated, but ruptured at 10 atmospheres (atm). The balloon catheter was removed and the lesion was successfully dilated with a new 1. 2 x 6 mm mini trek. An additional 2. 5 x 12 mm trek balloon was used for further dilatation. Rotoblation was performed, and a 3. 0 x 48 mm xience xpedition was used to successfully treat the lesion with a good result. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Subsequent to the initial report, the following information was provided: the 1. 2 x 6 mm mini trek balloon catheter was advanced to the lesion, but ruptured upon inflation. No additional information was 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 Key6186713
MDR Text Key63085004
Report Number2024168-2016-09012
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeTW
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 01/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Catalogue Number1012268-06
Device Lot Number51120G1
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 Received01/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2015
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: 12/19/2016 Patient Sequence Number: 1
Treatment
GUIDE WIRE: PROGRESS 140T
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