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 2009-05-07 for PERIMOUNT MAGNA EASE AORTIC SIZER 1133 manufactured by Edwards Lifesciences.
[1157135]
Reportedly, the sales rep received a bag of product from the customer containing "cracked sizers and handles". No additional information was provided. There was no indication as to the quantity or model type being returned. On 04/09/09, the device was received for evaluation. Althought it was asked, no information was provided as to the number of times used, number of times sterilized. It was apparently that the device had been used repeatedly. Sterilization and washing information has been requested (type of detergent/cleaner, additives, temperatures, times, etc. ). Unfortunately, as this is not a serialized device, no device history record (dhr) review can be done. However, it was learned that the hospital routinely sterilizes all sizers prior to each case regardless of the make and model used. No additional information is availabe.
Patient Sequence No: 1, Text Type: D, B5
[8390542]
Evaluation in process, not completed.
Patient Sequence No: 1, Text Type: N, H10
[8433433]
Evaluation summary attached: one minor crack was detected at the cylindrical polysufone plastic connection to the handle rod. Both ends, the cylindrical and the replica are attached and intact, no missing pieces detected. After review of the evaluation, this is no longer determined to be reportable per edwards lifesciences procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2009-10513 |
| MDR Report Key | 1376016 |
| Report Source | 01,05,06,07 |
| Date Received | 2009-05-07 |
| Date of Report | 2009-04-09 |
| Date of Event | 2009-04-09 |
| Date Facility Aware | 2009-04-09 |
| Date Mfgr Received | 2009-05-19 |
| Date Added to Maude | 2009-07-04 |
| 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 | SERVICE PERSONNEL |
| 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 | SIZER, HEART-VALVE, PROSTHESIS |
| Product Code | DTI |
| Date Received | 2009-05-07 |
| Returned To Mfg | 2009-04-09 |
| Model Number | 1133 |
| 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 | 2009-05-07 |