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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 1013155-20
Device Problems Difficult To Position (1467); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/26/2016
Event Type  malfunction  
Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information. Concomitant medical products: guide wire: sion, guide catheter: hyperion, stent: xience alpine 3. 0x38mm. The customer reported the device was discarded. Investigation is not yet complete. A follow up report will be submitted with all relevant information. The nc traveler is currently not commercially available in the u. S. ; however, it is similar to a device sold in the u. S.
 
Event Description
It was reported that during a procedure of the mildly tortuous, eccentric, moderately calcified, distal right coronary artery (rca), after stent implantation, the 3. 5 x 20 mm nc traveler balloon catheter was advanced, but met resistance with the stent. During inflation, the balloon ruptured at 10 atmosphere (atm). The balloon was removed and a different 3. 5 x 15 mm nc traveler balloon was used in the procedure. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was not returned for evaluation. 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 determined the reported difficulties appear to be related to circumstances of the procedure and there is no indication of a product quality issue with respects to the design, manufacture or labeling of the device.
 
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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 Key6265349
MDR Text Key65578241
Report Number2024168-2017-00575
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,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Catalogue Number1013155-20
Device Lot Number50904G1
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 Received01/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2015
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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