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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 1013155-15
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/31/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information. The nc traveler 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 during the procedure to treat a target lesion in the left anterior descending artery, an unspecified stent was implanted. Post stent implantation, the 3. 5 x 15 mm nc traveler was advanced to the target lesion for post-dilatation. The nc trek balloon was deflated and during removal, the shaft of the dilatation catheter separated into two segments at a location outside the patient anatomy. The separated segments were easily removed from the anatomy. The device was replaced with another device. There was no adverse patient effect. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Device not available for evaluation. 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 incidents from this lot. The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling during removal resulted in the reported shaft detachment. 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.
 
Manufacturer Narrative
(b)(4). Device available for evaluation. The device was returned for analysis. The reported detachment was confirmed.
 
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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 Key7343571
MDR Text Key102591175
Report Number2024168-2018-01875
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIN
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,Followup,Followup
Report Date 05/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Catalogue Number1013155-15
Device Lot Number70606G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2017
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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