20/30 PRIORITY PACK 20/30 INDEFLATOR 1000184

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 2020-03-11 for 20/30 PRIORITY PACK 20/30 INDEFLATOR 1000184 manufactured by Abbott Vascular.

Event Text Entries

[182994948] The device will not be returned for evaluation, the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10


[182994949] It was reported during a percutaneous coronary intervention (pci) procedure the 20/30 indeflator was pressurized and inflated the balloon to 10 atmospheres when it was noted to have a leak below the gauge inside the indeflator. Another indeflator was used to successfully complete the procedure. There was no patient adverse effects and no clinically significant delay. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-02275
MDR Report Key9819767
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-11
Date of Report2020-03-11
Date of Event2020-02-22
Date Mfgr Received2020-02-22
Device Manufacturer Date2019-09-23
Date Added to Maude2020-03-11
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 Name20/30 PRIORITY PACK 20/30 INDEFLATOR
Generic NameACCESSORIES
Product CodeMAV
Date Received2020-03-11
Model Number1000184
Catalog Number1000184
Lot Number60206719
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 2020-03-11

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