NC TREK RX 1012445-08

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 TREK RX 1012445-08 manufactured by Abbott Vascular.

Event Text Entries

[186380151] Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular 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 similar incidents reported from this lot. In this case, the device was prepped prior to use with no issue/ leak noted, which would suggest that the device was not damaged prior to use. The investigation determined the reported failure to advance and balloon rupture appear to be related to circumstances of the procedure. Based on the reported information, during advancement the balloon catheter encountered resistance with the heavily calcified, moderately tortuous anatomy. It is likely that during advancement the balloon became damaged or compromised causing the balloon to rupture the first inflation at 18 atmospheres. There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10


[186380152] It was reported that the procedure was to treat a de novo lesion in the heavily calcified, moderately tortuous posterior descending coronary artery. The 2. 00x8 mm nc trek balloon dilatation catheter (bdc) was advanced with resistance with the anatomy noted and inflated once to 18 atmospheres for 10 seconds and ruptured due to the heavy calcium. A non-abbott bdc was used to continue the procedure. There were no adverse patient effects and there was no reported clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-03165
MDR Report Key9907980
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-02-28
Date Mfgr Received2020-03-10
Device Manufacturer Date2018-10-22
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 TREK RX
Generic NameCORONARY DILATATION CATHETER
Product CodeLOX
Date Received2020-03-31
Model Number1012445-08
Catalog Number1012445-08
Lot Number81022G1
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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