HT BALANCE GUIDE WIRE 1001780-HC

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 2020-03-20 for HT BALANCE GUIDE WIRE 1001780-HC manufactured by Abbott Vascular.

Event Text Entries

[184437481] The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The first bmw guide wire referenced is filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10


[184437482] It was reported that first balance middle weight (bmw) guide wire was advanced towards the right coronary artery, but the guide wire was unable to cross the artery and became kinked. It was difficult to remove the guide wire from the anatomy. A second bmw guide wire was inserted and had the same issue as the first bmw guide wire. A non-abbott guide wire was used to complete the procedure. 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


[188948636] 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. There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties. The investigation determined the reported difficulties appears to be related to operational circumstances of the procedure. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2024168-2020-02703
MDR Report Key9860455
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-20
Date of Report2020-03-20
Date of Event2020-01-24
Date Mfgr Received2020-02-28
Device Manufacturer Date2019-09-20
Date Added to Maude2020-03-20
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 BALANCE GUIDE WIRE
Generic NameGUIDE WIRE
Product CodeDQX
Date Received2020-03-20
Model Number1001780-HC
Catalog Number1001780-HC
Lot Number9092071
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 2020-03-20

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