HT COMMAND 14 2078175

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 COMMAND 14 2078175 manufactured by Abbott Vascular.

Event Text Entries

[185001473] The device is expected to be returned for investigation. 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


[185001494] It was reported the procedure was to treat a total occlusion in the anterior descending artery. A ht command 14 guide wire was used with a non-abbott support catheter; however, the coating of the guide wire ripped off and the support catheter became blocked. The procedure was successfully completed with a new non-abbott support catheter and new ht command 14 guide wire. There were no reported 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 Number2024168-2020-02912
MDR Report Key9881628
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-03-03
Date Mfgr Received2020-03-03
Device Manufacturer Date2019-11-01
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 # 3005737652
Manufacturer StreetROAD NO.2 KM 58.0 CRUCE D
Manufacturer CityBARCELONETA PR 00617
Manufacturer CountryUS
Manufacturer Postal Code00617
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHT COMMAND 14
Generic NameGUIDE WIRE
Product CodeDQX
Date Received2020-03-25
Model Number2078175
Catalog Number2078175
Lot Number9110171
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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