HT TURNTRAC 1020010J

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 2020-03-25 for HT TURNTRAC 1020010J manufactured by Abbott Vascular.

Event Text Entries

[185001250] 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.
Patient Sequence No: 1, Text Type: N, H10


[185001251] It was reported that the procedure was performed to treat multiple lesions in the right coronary artery. The procedure was performed without issue; however, after removal of the 014 ht turntrac flex guide wire the proximal portion of the guide wire was observed to be frayed. The procedure was successfully completed at this time. 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 Number2024168-2020-02905
MDR Report Key9881345
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Device Manufacturer Date2019-01-28
Date Added to Maude2020-03-25
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, REG # 2024168
Manufacturer Street26531 YNEZ ROAD
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal Code925914628
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHT TURNTRAC
Generic NameGUIDE WIRE
Product CodeDQX
Date Received2020-03-25
Catalog Number1020010J
Lot Number9012861
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 2020-03-25

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