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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR NC TRAVELER RX CORONARY DILATATION CATHETER

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ABBOTT VASCULAR NC TRAVELER RX CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1013155-08
Device Problems Material Rupture (1546); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/12/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2019001. 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 similar incidents and/or complaints from this lot. The investigation determined the reported difficulties appear 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. 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 the procedure was performed to treat a lesion in the mid right coronary artery that was moderately calcified, moderately tortuous and 90% stenosis. The nc traveler balloon dilatation catheter (bdc) was advanced against resistance to the lesion. The balloon ruptured during the second inflation at 14 atmospheres. There was no reported adverse patient effect or a clinically significant delay in the procedure. The bdc was replaced with a non-abbott bdc for dilatation and an unspecified drug-eluting stent was implanted to complete the procedure. No additional information was provided.
 
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Brand NameNC TRAVELER RX
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key9532827
MDR Text Key178164207
Report Number2024168-2019-15092
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 12/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1013155-08
Device Lot Number91010G1
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 Received12/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/10/2019
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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