CARPENTIER-EDWARDS MITRAL ANNULOPLASTY SIZER 1174M

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2009-03-26 for CARPENTIER-EDWARDS MITRAL ANNULOPLASTY SIZER 1174M manufactured by Edwards Lifesciences.

Event Text Entries

[1157865] Through repeated follow up with the customer, it was learned through email that one of the current detergents used by the customer is not recommended as a cleaning agent for the material of the sizer. The detergent is hamo liquid 36. A copy of the caution statement was provided to the customer. According to the detergents information on use: "the use of drying/rinsing aids leaves traces of surfactants on surfaces. These surfaces, in combination with steam sterilization, can lead to stress cracking in certain plastic structures under tension. " the caution statement specifically references ppsu (polyphenylsulfone). This material is more chemically resistant than the polysulfone used in the sizers. Therefore, hamo liquid 36 should not be used with edwards sizers. This information has been provided to the customer.
Patient Sequence No: 1, Text Type: D, B5


[8463142] Evaluation summary attached: received one set of sizers in tray. Several cracks and crazing marks were observed on the sizer. There were no visible missing pieces.
Patient Sequence No: 1, Text Type: N, H10


[17866450] Reportedly a crack was observed on the sizers after washing and sterilization. It was the first time to use this sizer. Customer washed the device with sponge and dishwashing detergent (manufacturer: p&g, trade name: joy) and washed with enzymatic detergent for protein removal (manufacturer: steris, trade name: enzycare2 (1041-08, 1gal)). Devices were put in the stainless basket and washed in the surgical instruments washer. (washing at 70 degrees centigrade, rinsing at 90 degrees centigrade and drying at 110 degrees centigrade. 70mins total. ) then reportedly, the device was sterilized by eog sterilization (60 degrees centigrade, 300mins total). No additional information provided. Device returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5


[18012470] Pending evaluation completion.
Patient Sequence No: 1, Text Type: N, H10


[18208378] Safety risk was evaluated and product risk assessment was conducted. As a result of the risk assessment, capa was opened and has addressed this issue. This is no longer reportable per edwards lifesciences procedures.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2015691-2009-10151
MDR Report Key1351365
Report Source01,05,06,07
Date Received2009-03-26
Date of Report2009-02-25
Date of Event2009-02-21
Date Facility Aware2009-02-21
Date Mfgr Received2009-05-27
Date Added to Maude2009-06-21
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 FDA0
Event Location3
Manufacturer ContactMR. NEIL LANDRY
Manufacturer StreetONE EDWARDS WAY MAILSTOP: MS HVC96
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9492502289
Manufacturer G1EDWARDS LIFESCIENCES LLC
Manufacturer StreetONE EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal Code92614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARPENTIER-EDWARDS MITRAL ANNULOPLASTY SIZER
Generic NameMITRAL ANNULOPLASTY SIZER
Product CodeDTI
Date Received2009-03-26
Returned To Mfg2009-03-05
Model Number1174M
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES
Manufacturer AddressONE EDWARDS WAY IRVINE CA 92614 US 92614


Patients

Patient NumberTreatmentOutcomeDate
10 2009-03-26

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