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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT TRAVELER RX CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1013067-15
Device Problems Difficult To Position (1467); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/19/2017
Event Type  malfunction  
Manufacturer Narrative
Internal file number - (b)(4). Evaluation summary: visual, dimensional and functional inspections were performed on the returned device. The reported difficulty positioning the balloon dilatation catheter (bdc) over the guide wire and the reported difficulty removing the bdc from the guide wire were not confirmed. 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. 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.
 
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 additional relevant information. The traveler device is currently not commercially available in the us; however, it is similar to a device sold in the us.
 
Event Description
It was reported that the procedure was to treat a mildly calcified mid left anterior descending artery that was 90% stenosed. While advancing a 2. 5 x 15 mm rx traveler balloon catheter over an unspecified guide wire, the catheter got stuck on the guide wire before the catheter entered the anatomy. There was resistance removing the catheter and the devices had to be removed as a single unit. The catheter was then removed and the same guide wire was used with another catheter to successfully complete the procedure. There was no clinically significant delay in procedure and no adverse patient effects. No additional information was provided.
 
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Brand NameTRAVELER RX 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 Key7028797
MDR Text Key245972217
Report Number2024168-2017-08944
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Catalogue Number1013067-15
Device Lot Number70327G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2017
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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