23MM X 4CM X 130CM EDWARDS BALLOON CATHETER 9350BC23 9350BC23A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-02 for 23MM X 4CM X 130CM EDWARDS BALLOON CATHETER 9350BC23 9350BC23A manufactured by Edwards Lifesciences Llc.

Event Text Entries

[90878076]
Patient Sequence No: 1, Text Type: N, H10


[90878077] During deployment of the edwards tavr valve the inflation balloon ruptured and valve was unable to be deployed - although it did expand enough to prevent the valve to be retracted back in the delivery sheath - the valve was ultimately removed from the access site of the lt subclavian artery with a cut down and patch grafting needed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6995835
MDR Report Key6995835
Date Received2017-11-02
Date of Report2017-10-25
Date of Event2015-10-23
Report Date2017-10-25
Date Reported to FDA2017-10-25
Date Reported to Mfgr2017-10-25
Date Added to Maude2017-11-02
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name23MM X 4CM X 130CM EDWARDS BALLOON CATHETER
Generic NameBALLOON AORTIC VALVULOPLASTY
Product CodeOZT
Date Received2017-11-02
Model Number9350BC23
Catalog Number9350BC23A
OperatorPHYSICIAN
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES LLC
Manufacturer AddressONE EDWARDS WAY IRVINE CA 92614 US 92614


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-02

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