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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT NC TRAVELER CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1013150-12
Device Problems Collapse (1099); Difficult to Remove (1528)
Patient Problem No Patient Involvement (2645)
Event Date 09/09/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. 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 identified no other similar incidents from this lot. 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. The investigation was unable to determine a conclusive cause for the reported difficult to remove protective sheath; however the flared tip appears to be related to operational context. The traveler is currently not commercially available in the u. S. However, it is similar to a device sold in the us.
 
Event Description
It was reported that the 2. 25 x 12 mm nc traveler rx balloon dilatation catheter was observed to have a flared tip after it was unpacked. Resistance was felt during the removal of the protective sheath and force was applied. The device was not used in the patient and a replacement 2. 5 x 15 mm traveler rx was used to dilate the lesion. The procedure was successfully completed after a xience alpine stent was implanted. There was no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameNC TRAVELER 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 Key5998138
MDR Text Key56473990
Report Number2024168-2016-06644
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K110134
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
Report Date 10/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2017
Device Catalogue Number1013150-12
Device Lot Number40805G1
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 Received09/16/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2014
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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