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 2009-05-21 for PERIMOUNT MAGNA EASE AORTIC SIZER 1133 manufactured by Edwards Lifesciences.
[1129438]
Reportedly, the sales rep received sizers from the customer stating there were "cracks". The customer also stated that due to the volumn of procedures "it is unknown how long these devices were in place or how many times they were sterilized. " no serial numbers are available for these devices; therefore, no device history record (dhr) review can be done. Requested detailed information on the cleaning and sterilization methods used, cleaning agents, additives, etc. At 05/21/2009 no additional information has been received to date. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[8146203]
Evaluation summary attached: the cylindrical end and the replica end exhibited cracks at the polyphenylsulfone plastic connection to the handle rod. Only cylindrical end remained attached to the handle rod. No visible broken pieces were detected from the sizers.
Patient Sequence No: 1, Text Type: N, H10
[8435053]
This device was previoiusly reported on manufacturer's report # 2015691-2009-10489. Therefore, initial emdr # 2015691-2009-10633 is void.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2009-10633 |
| MDR Report Key | 1391725 |
| Report Source | 01,05,06,07 |
| Date Received | 2009-05-21 |
| Date of Report | 2009-04-09 |
| Date of Event | 2009-04-09 |
| Date Facility Aware | 2009-04-09 |
| Date Mfgr Received | 2009-04-27 |
| Date Added to Maude | 2009-07-07 |
| 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 |
| Reporter Occupation | HOSPITAL SERVICE TECHNICIAN |
| 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 | PERIMOUNT MAGNA EASE AORTIC SIZER |
| Generic Name | AORTIC VALVE SIZER |
| Product Code | DTI |
| Date Received | 2009-05-21 |
| Returned To Mfg | 2009-04-09 |
| Model Number | 1133 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2009-05-21 |