NC TREK RX 1012451-15

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for NC TREK RX 1012451-15 manufactured by Abbott Vascular.

Event Text Entries

[185726355] The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information. The additional 4x15mm and 4x12mm nc trek devices referenced are filed under a separate medwatch report numbers.
Patient Sequence No: 1, Text Type: N, H10


[185726356] It was reported that the procedure was to treat an unspecified lesion. Three (4x15mm, 3. 5x15mm, and 4x12mm) nc trek balloon dilatation catheters were attempted to be inserted when the shaft for all three devices became separated. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-03136
MDR Report Key9903794
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-11-08
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 Number1012451-15
Catalog Number1012451-15
Lot Number91108G1
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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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