MILLER BALLOON ATRIOSEPTOSTOMY CATHETER 830515F

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for MILLER BALLOON ATRIOSEPTOSTOMY CATHETER 830515F manufactured by Edwards Lifesciences, Pr.

Event Text Entries

[132348825] The product is expected to be returned for analysis; however, it has not yet been received. Upon the return of the product a supplemental report will be sent with the investigation results. A device history record review was completed and documented that the device met all specifications upon distribution.
Patient Sequence No: 1, Text Type: N, H10


[132348826] It was reported that the balloon on a miller balloon atrioseptostomy catheter detached during use in a (b)(6) male infant. The issue occurred while the balloon was inflated and being pulled through the right atrium of the heart. The balloon was left inside the infant? S right atrium and he was transferred to another hospital where he underwent a? Major invasive procedure with higher cost? In order to remove the detached balloon. As per follow-up, the infant was transferred back to the original treating hospital and was doing well after removal of the detached balloon.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2015691-2019-00022
MDR Report Key8210893
Date Received2019-01-02
Date of Report2018-12-13
Date of Event2018-12-06
Date Mfgr Received2019-02-14
Device Manufacturer Date2018-04-20
Date Added to Maude2019-01-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. SAMANTHA EVELEIGH
Manufacturer StreetONE EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9492503939
Manufacturer G1EDWARDS LIFESCIENCES, PR
Manufacturer StreetSTATE RD INDUS PK 402 KM 1.4
Manufacturer CityANASCO PR 00610
Manufacturer CountryUS
Manufacturer Postal Code00610
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMILLER BALLOON ATRIOSEPTOSTOMY CATHETER
Generic NameCATHETER, SEPTOSTOMY
Product CodeDXF
Date Received2019-01-02
Returned To Mfg2019-01-15
Model Number830515F
Catalog Number830515F
Lot Number61332460
Device Expiration Date2019-07-13
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES, PR
Manufacturer AddressSTATE RD INDUS PK 402 KM 1.4 ANASCO PR 00610 US 00610


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention 2019-01-02

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