NC TRAVELER RX 1013159-08

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-31 for NC TRAVELER RX 1013159-08 manufactured by Abbott Vascular.

Event Text Entries

[186376082] 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.
Patient Sequence No: 1, Text Type: N, H10


[186376083] It was reported that the procedure was performed to treat a lesion in the heavily calcified left anterior descending (lad) artery. Resistance was met during advancement, due to the patient anatomy. The 5. 0 x 8 mm nc traveler dilatation catheter was inflated to perform post dilatation of a xience sierra stent. During inflation to 10 atmospheres (atm), the balloon ruptured. It was noted that the air pressure inside the indeflator failed to rise and contrast leakage was noted on angiography. The nc traveler dilatation catheter was removed without resistance and post dilatation was performed using a non-abbott dilatation catheter. There were no adverse patient effects and no clinically significant delay. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-03175
MDR Report Key9908295
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-09
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-04-12
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LINDSEY BELL
Manufacturer Street26531 YNEZ RD.
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal925914628
Manufacturer Phone9519143996
Manufacturer G1ABBOTT VASCULAR COSTA RICA, REG # 3009564766
Manufacturer Street52 CALLE 3 B31 COYOL FREE ZONE
Manufacturer CityEL COYOL ALAJUELA
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNC TRAVELER RX
Generic NameCORONARY DILATATION CATHETER
Product CodeLOX
Date Received2020-03-31
Catalog Number1013159-08
Lot Number90412G1
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT VASCULAR
Manufacturer Address26531 YNEZ RD. TEMECULA CA 925914628 US 925914628


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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