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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 1012270-12
Device Problems Detachment Of Device Component (1104); Kinked (1339); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/08/2017
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 is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a heavily tortuous left anterior descending artery. A 2. 0 x 12 mm mini trek balloon catheter was being advanced when there was strong resistance due to the tortuosity in the anatomy and the shaft kinked. The physician straightened the kinked shaft, but the catheter was pushed harder and the shaft separated proximal to the kinked area. The device was easily removed and another balloon catheter was successfully used to complete the procedure. There was no clinically significant delay in procedure and no adverse patient effects. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Failure to follow steps/instructions. The device was not returned for analysis. 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 did not indicate a lot specific quality issue. It should be noted that the trek rx / mini trek rx coronary dilatation catheter (cdc), global instructions for use (ifu, warnings section) specifies: if resistance is felt, determine the cause of the resistance before proceeding. Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and/or damage / separation of the catheter. Additionally, it should be noted that the trek rx / mini trek rx coronary dilatation catheter (cdc), global ifu specifies: do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking. Instead, prepare a new catheter. The investigation determined the reported failure to advance appears to be related to circumstances of the procedure; however, the reported kink and shaft separation appears to be related to the use errors. There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
 
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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 Key6393691
MDR Text Key69817142
Report Number2024168-2017-01981
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 04/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Catalogue Number1012270-12
Device Lot Number61111G1
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 Received04/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2016
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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