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 2011-03-14 for CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER 1130 manufactured by Edwards Lifesciences.
[1915481]
The customer reported that a heart valve sizer was used for sizing on (b)(6) 2011. During sizing, the sizer attached to the handle got broken and detached from the handle. Broken pieces were dropped in the operative field so that customer collected and removed the pieces. Customer reported no patient injury or complication as of (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
[8836415]
Method: device not returned. Additional manufacturer narrative: a device history record review will not be done as this is not a serialize device. The device is being returned for evaluation. The length of time this device has been in server, number of times sterilized, type of sterilizer, cleaning agents, number of times used, has been asked but not answered to date.
Patient Sequence No: 1, Text Type: N, H10
[9022714]
Evaluation summary attached: as received the cylindrical end is detached from the rod. Broken pieces are evident in the polysulfone plastic connection to the handle rod; the broken pieces are returned. Crazing is also noted in the cylindrical end. Two broken off piece are returned along the sizer. Both pieces fit together and match and complete the connection end. The replica end is attached to the rod and is intact. However, cracks and crazing are detected at polysulfone plastic connection to the handle rod. The returned device was examined visually and with a light microscope (b)(4), digital microscope (b)(4). Additional manufacturer narrative: the methods, number of cycles, detergents and parameters used for cleaning and sterilization were not disclosed by the customer. Without knowing the specific chemical agents the sizers were exposed to, or the cleaning and sterilization protocol followed by the hospital, or the number of times these devices were put through the cleaning and sterilization cycle, we are unable to make any comment regarding the durability for these specific devices or the root cause for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2011-15026 |
| MDR Report Key | 2016822 |
| Report Source | 01,05,06,07 |
| Date Received | 2011-03-14 |
| Date of Report | 2011-02-18 |
| Date of Event | 2011-02-17 |
| Date Facility Aware | 2011-02-17 |
| Date Mfgr Received | 2011-03-23 |
| Date Added to Maude | 2011-03-14 |
| 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 AORTIC ANNULOPLASTY VALVE SIZER |
| Generic Name | ANNULOPLASTY VALVE SIZER |
| Product Code | DTI |
| Date Received | 2011-03-14 |
| Returned To Mfg | 2011-03-10 |
| Model Number | 1130 |
| 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 | 1. Required No Informationntervention | 2011-03-14 |