MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-05-05 for CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER 1130 manufactured by Edwards Lifesciences.
[1501194]
It was reported that an 1130, 27mm sizer for the magna aortic valve broke during use. No patient injury. No additional information is available at this time. Capa# (b) (4) and (b) (4). 04/23/10 e-mail from sales representative with hospital's response indicates that the sizer was used at least once to twice per day, steam was used to sterilize the device, and an enzymatic detergent called (b) (6) clean made by (b) (4) is used to soak the tray after it comes off of the field in out sub sterile room off of the caridiac ors. The sizers are sterilized in large steam sterilizers on the 6th floor according to industry standards, they are also put through an hour long wash, cleanse and rinse cycles in sterile equipment processing department before sterilization. Was there an injury? No
Patient Sequence No: 1, Text Type: D, B5
[8643737]
(b) (4) = sizer for the magna aortic valve broke during use. Evaluation summary: received (1) 25 mm sizer. As received, the replica end was detached from the handle rod and missing a piece. The broken piece had a length of approximately 17mm and matched up with the sizer. The cylindrical end exhibited cracks at the handle rod connection to the polysulfone plastic. This event was determined to be reportable per edwards lifesciences procedures. The event was learned through via telephone call from (b) (4) sales representative. A device history record was not possible due to no lot/serial number is available. Device was received and evaluated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2010-13283 |
| MDR Report Key | 1675084 |
| Report Source | 05,06,07 |
| Date Received | 2010-05-05 |
| Date of Report | 2010-04-09 |
| Date of Event | 2010-04-09 |
| Date Facility Aware | 2010-04-09 |
| Date Mfgr Received | 2010-04-09 |
| Date Added to Maude | 2010-05-05 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | 2010-05-05 |
| Model Number | 1130 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2010-05-05 |