HYPERFORM 104-4470

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 2020-03-18 for HYPERFORM 104-4470 manufactured by Micro Therapeutics, Inc. Dba Ev3.

Event Text Entries

[183937747] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[183937748] Medtronic received a report that the hyperform balloon ruptured. It was reported that the hyperform balloon catheter was prepared as per the instructions for use (ifu) and inflated during preparation with no issue. During the procedure, the balloon was inflated and deflated twice, but when inflated a third time, the balloon failed to stay inflated. Once removed, it was found the balloon had ruptured. Another device was used to complete the procedure with no issues and there was no patient harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2029214-2020-00251
MDR Report Key9848468
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-18
Date of Report2020-03-18
Date of Event2020-03-15
Date Mfgr Received2020-03-15
Device Manufacturer Date2019-07-06
Date Added to Maude2020-03-18
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 ContactKATCHA TAYLOR
Manufacturer Street9775 TOLEDO WAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9496801345
Manufacturer G1MICRO THERAPEUTICS, INC. DBA EV3
Manufacturer Street9775 TOLEDO WAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHYPERFORM
Generic NameCATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
Product CodeMJN
Date Received2020-03-18
Model Number104-4470
Catalog Number104-4470
Lot NumberA859803
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMICRO THERAPEUTICS, INC. DBA EV3
Manufacturer Address9775 TOLEDO WAY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-18

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