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 2010-06-12 for CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER 1130 manufactured by Edwards Lifesciences.
[17069751]
Allegedly the patient has acute fracture of femur distal to the primary stem.
Patient Sequence No: 1, Text Type: D, B5
[17244045]
(b) (4)
Patient Sequence No: 1, Text Type: N, H10
[17864645]
It was reported that during a percutaneous coronary intervention treatment procedure, a balloon rupture occurred. The physician was treating a 90% stenosed lesion located in the moderately tortuous and severely calcified mid right coronary artery (rca). The lesion was crossed with an unspecified guide wire and the lesion was dilated twice at 12atms with another manufacturers' 2. 0mm balloon catheter. This 3. 0x15mm quantum maverick balloon catheter was used for further dilation and the balloon ruptured "around 5atms". A pinhole rupture was noted in the balloon after withdrawal from the patient. The procedure was completed with another manufacturers' balloon catheter. There were no reported patient complications. The patient status is listed as good. Additional information has been requested and is not available.
Patient Sequence No: 1, Text Type: D, B5
[17922956]
Evaluation summary: the cylindrical end is detached from the handle rod due to a broken piece of the polysufone plastic at the connection site. The broken piece was not returned. The replica end is intact yet exhibits crazing at polysufone plastic connection to the handle rod. No device history record was done because no lot/serial number was provided.
Patient Sequence No: 1, Text Type: N, H10
[22047937]
(b) (4) = "1130, 27mm sizer for the magna aortic valve broke when the surgeon bent it prior to placing in the patient for sizing. " device evaluation anticipated, but not yet begun. This event was determined to be reportable per edwards lifesciences procedures. The event was learned through (b) (4) sales representative. A device history record is not possible due to no lot/ serial number was provided.
Patient Sequence No: 1, Text Type: N, H10
[22235146]
It was reported by (b) (4) sales representative that an 1130, 27mm sizer for the magna aortic valve broke when the surgeon bent it prior to placing in the patient for sizing. No patient injury/involvement. The sizer is available and will be returned by sales representative. No patient injury. No additional information is available at this time. Capa# (b) (4) and (b) (4). 05/17/10 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 insta 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 cardiac 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. On 05/17/10, telephone call to sales representative and i asked sales representative if there were multiple pieces when the sizer broke or if there was simply cracks or crazing where the sizer handle attaches to the sizer and sales representative stated that it looks like the handle has simply separated from the sizer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2010-13565 |
| MDR Report Key | 1721384 |
| Report Source | 05,06,07 |
| Date Received | 2010-06-12 |
| Date of Report | 2010-05-14 |
| Date of Event | 2010-05-14 |
| Date Facility Aware | 2010-05-14 |
| Date Mfgr Received | 2010-06-13 |
| Date Added to Maude | 2010-07-13 |
| 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: 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 RING SIZER |
| Product Code | DTI |
| Date Received | 2010-06-12 |
| Returned To Mfg | 2010-05-25 |
| 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 | 2010-06-12 |