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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 1013153-12
Device Problems Material Rupture (1546); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2016
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. Concomitant medical products: guide wire: sion blue. Guide catheter: hyperion al. The nc traveler is currently not commercially available in the us; however, it is similar to a device sold in the us. The customer reported the device was discarded. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a de novo lesion in the moderately tortuous, heavily calcified, 99% stenosed mid right coronary artery. A 3. 00 x 12 mm nc traveler rx balloon dilatation catheter (bdc) was selected for pre-dilatation. The bdc was advanced against resistance to the lesion and crossed. Upon the first inflation to 15 atmospheres the balloon ruptured as evidenced by contrast escaping from balloon under angiography. The bdc was removed from the anatomy and when flushed a longitudinal rupture was noted at middle of balloon. A non-abbott bdc was used to complete the pre-dilatation and the procedure was completed with the successful implantation of a xience alpine stent. There was no reported clinically significant delay in the procedure. There was no reported adverse patient sequela. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was not returned for evaluation. However, there was no leak noted during preparation prior to use, which suggests a product quality issue did not contribute to the reported difficulties. In this case it is likely that the balloon interacted with the moderately tortuous, heavily calcified and 99% stenosed lesion such that the balloon became damaged and subsequently ruptured during inflation. The same anatomical conditions likely contributed to the resistance met during advancement. 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 difficulty appears to be related to circumstances of the procedure. 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 Key6191987
MDR Text Key63219859
Report Number2024168-2016-09085
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 01/09/2017
1 Device was Involved in the Event
1 Patient was 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 Date07/31/2018
Device Catalogue Number1013153-12
Device Lot Number50824G1
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 Received12/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/20/2016 Patient Sequence Number: 1
Treatment
CONCOMITANT MEDICAL DEVICES
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