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.
[1063934]
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) 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
[8218701]
Pending evaluation completion.
Patient Sequence No: 1, Text Type: N, H10
[8437113]
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
[20922816]
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
[21194453]
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
| Report Number | 2015691-2009-10152 |
| MDR Report Key | 1351366 |
| Report Source | 01,05,06,07 |
| Date Received | 2009-03-26 |
| Date of Report | 2009-02-25 |
| Date of Event | 2009-02-21 |
| Date Facility Aware | 2009-02-21 |
| Date Mfgr Received | 2009-05-27 |
| Date Added to Maude | 2009-06-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR. NEIL LANDRY |
| Manufacturer Street | ONE EDWARDS WAY MAILSTOP: MS HVC96 |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492502289 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARPENTIER-EDWARDS MITRAL ANNULOPLASTY SIZER |
| Generic Name | MITRAL ANNULOPLASTY SIZER |
| Product Code | DTI |
| Date Received | 2009-03-26 |
| Returned To Mfg | 2009-03-05 |
| Model Number | 1174M |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-26 |