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 2012-04-04 for OBTURATOR, MITRAL SIZER 1162 manufactured by Edwards Lifesciences.
[2598217]
The operating room nurse reported that, during use, the connector with handle was broken; but there were no segments that fell in the patient body.
Patient Sequence No: 1, Text Type: D, B5
[9948578]
Method: device evaluation anticipated; but not yet begun. Conclusion: device evaluation anticipated; but not yet begun. No patient information has been provided. No device maintenance information has been provided. This is not a serialized device; therefore, no device history record (dhr) review cannot be done.
Patient Sequence No: 1, Text Type: N, H10
[17643317]
Evaluation summary: customer claim of connector with handle broken was confirmed. The broken off piece was returned. The piece, which is the threaded section of the handle attachment, was a match with the sizer. No other pieces were broken off form the sizer. Customer reported washing and sterilization procedures were applied to this device in excess of 20 times over the course of 1 - 1/2 years. Tasks were conducted by an washing center and procedures are unknown. However, they do know that the device was sterilized using hydrogen peroxide (h2o2) gas/plasma which is not recommended for this type material. Cleaning process remains unknown. Additional engineering evaluation pending.
Patient Sequence No: 1, Text Type: N, H10
[20966456]
Engineering evaluation: the model 1162, 29mm sizer was returned and evaluated by the product evaluation lab. However, the device was inadvertently disposed. Therefore, engineering conducted its investigation based on the evaluation pictures provided by the product evaluation lab. Based on a visual observation of the pictures of the sizer, the only defect on the sizer appeared to be at the central hub where the handle attaches to the sizer. There were no apparent cracks, surface crazing, or hazy surface appearance at any other point on the sizer that would have indicated chemical affects due to long term use and a high number of cleaning and sterilization cycles. A root cause of the fracture could not conclusively be determined since the sizer was inadvertently disposed of prior to the engineering investigation. However, the fracture did not appear to be a typical stress crack due to chemical exposures. The fracture appeared to be located where the central hub extends beyond the web connection. A fracture of this nature could occur if the handle is screwed onto the sizer beyond its natural stopping position, i. E. Over torque, thereby pushing off the extended portion of the hub containing the threads. From the pictures provided, it could not be determined if there were any micro cracks or defects in the molded sizer that would weaken the material in this area. Edwards has validated valve sizers up to 50 cleaning and sterilization cycles. In addition, sizers are inspected upon receiving for cracks and defects per first article inspection. The sizers must be free from distortions, cracks, misfills, and burns affecting part function. Air bubbles and foreign particles larger than 0. 020" are not acceptable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2012-17219 |
| MDR Report Key | 2517142 |
| Report Source | 01,05,06,07 |
| Date Received | 2012-04-04 |
| Date of Report | 2012-03-06 |
| Date of Event | 2012-03-03 |
| Date Facility Aware | 2012-03-03 |
| Date Mfgr Received | 2012-06-04 |
| Date Added to Maude | 2012-09-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NEIL LANDRY |
| Manufacturer Street | ONE EDWARDS WAY MAILSTOP: PRT 46 |
| 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 | OBTURATOR, MITRAL SIZER |
| Generic Name | ANNULOPLASTY RING SIZER |
| Product Code | DTI |
| Date Received | 2012-04-04 |
| Returned To Mfg | 2012-03-27 |
| Model Number | 1162 |
| 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 | 2012-04-04 |