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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 Kinked (1339); Difficult to Remove (1528)
Patient Problem No Patient Involvement (2645)
Event Date 12/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The nc traveler device is currently not commercially available in the us; however, it is similar to a device sold in the us. The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that a 3. 50x20mm nc traveler balloon dilatation catheter (bdc) was removed from the dispenser coil and an attempt to remove the protective sheath was made; however, the sheath was tight and it could not be removed. The procedure was successfully completed with a 3. 5x20mm nc traveler bdc. After the procedure another attempt was made to remove the protective sheath with force and the sheath was able to be removed. It was noticed that the hub was kinked but it was stated that this is probably due to the handling during preparation. There was no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: the device was returned for analysis and the reported resistance to remove the balloon protective sheath was confirmed. The inner diameter of the sheath met specification. The reported kink was confirmed. Based on an expanded investigation and further review of the complaint handling database and other sources of nonconformity data, it was determined that the device's performance with regards to the difficulty with removing the protective sheath appear to be related to normal variation found in manufacturing. The performance of these devices will continue to be monitored.
 
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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 Key6192004
MDR Text Key63210262
Report Number2024168-2016-09086
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,Followup
Report Date 04/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2018
Device Catalogue Number1013155-20
Device Lot Number50525G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/16/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2015
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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