MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-03-05 for PERIMOUNT MAGNA EASE SIZER 1133 manufactured by Edwards Lifesciences.
[4282870]
As reported, the metal handle of the sizer was detached from the cylindrical end while attempting to size the patient? S annulus. It was reported that upon inspection of the sizer head, a small piece was missing on the inside lip of the sizer, close to the attachment point of the handle. The missing piece was not located. The sizer was not inspected prior to use. Based on our follow-up, it was learned that the sizer was in the hospital for more than three (3) years and has been sterilized approximately 100 times using gigasept af and steam under 134 degrees for 5 minutes. There were no adverse patient effects reported as a result of the reported event. The subject device has been discarded in the hospital. No other details reported.
Patient Sequence No: 1, Text Type: D, B5
[11577122]
The subject device is no longer available for evaluation as it was discarded at the hospital. Therefore, we are unable to confirm the event and to determine root cause for the reported event. Per the product instructions for use (ifu) list time and temperature guidelines as well as equipment and solution recommendations for by hand and by machine cleaning and sterilization. Included in the ifu is the following statement: "caution: examine sizers and handles for signs of wear, such as dullness, cracking or crazing. Replace sizer/handle if any deterioration is observed. " it is assumed this event occurred because the device was not examined and inspected as recommended by the ifu.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2014-00523 |
| MDR Report Key | 3661611 |
| Report Source | 01,05,06 |
| Date Received | 2014-03-05 |
| Date of Report | 2014-02-05 |
| Date of Event | 2014-02-04 |
| Date Mfgr Received | 2014-02-05 |
| Date Added to Maude | 2014-03-05 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR. NEIL LANDRY |
| Manufacturer Street | 1 EDWARDS WAY MS: LFS 33 |
| 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 SIZER |
| Generic Name | SIZER, HEART-VALVE, PROSTHESIS |
| Product Code | DTI |
| Date Received | 2014-03-05 |
| Model Number | 1133 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2014-03-05 |