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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012274-15
Device Problems Loose or Intermittent Connection (1371); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Evaluation summary: visual and functional inspections were performed on the returned device. The reported loose or intermittent connection was confirmed. In this case, it is possible that the inflation device was over torqued/tightened during connection to the hub of the device, resulting in the crack in the hub and subsequent leaking; however this cannon be confirmed. Additionally, the guide wire exit notch was torn distally. The tearing of the guide wire exit notch appears to have resulted from an interaction with the guide wire. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. A review of the complaint history identified no other similar incidents from this lot. The investigation determined the reported difficulty appears to be related to circumstances of the procedure. There is no indication of a product quality issue with respects to the design, manufacturing, or labeling of the device.
 
Event Description
It was reported that the procedure was to treat a mildly tortuous, mildly calcified lesion in the left anterior descending coronary artery. Reportedly, the 3. 00 x 15 mm trek rx was at the target lesion; however, when an attempt to dilate the balloon with a manometer was made the contrast media sprayed out of the connection between the trek rx and manometer. A second manometer was used to again try to dilate the balloon with the same result. No contrast reached the balloon. Both manometers were used with other balloons and stent successfully. The procedure was successfully completed with another device. There was no clinically significant delay in the procedure and no adverse patient effects. No additionally information was provided. Return device analysis revealed the shaft was torn at the guide wire exit notch.
 
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Brand NameTREK 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 Key6215685
MDR Text Key63825004
Report Number2024168-2016-09388
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFI
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
Report Date 12/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Catalogue Number1012274-15
Device Lot Number51111G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2016
Was Device Evaluated by Manufacturer? Yes
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

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