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 2011-08-05 for N/A 29403-K manufactured by Stryker Sustainability Solutions.
[2128333]
It was reported that during the procedure the suction at the end of the arm of the cardiac stabilization device was not holding properly and caused the device to drag which caused abrasions to the heart tissue. The user facility stated there was no treatment needed.
Patient Sequence No: 1, Text Type: D, B5
[9149408]
The device was returned to stryker sustainability solutions (sss) without any packaging or labeling so device information such as lot number, manufacture date, and expiration date are all unknown. The device was subjected to in-line inspection and was rejected due to the ball bearing between the claw lumen being cracked. This ball is used for positioning purposes only and has no bearing on the suction capabilities. The bearing most likely cracked during clinical use and/or transit back to sss. The returned device was tested to confirm the device was able to maintain suction. The device passed all function testing. Based on the evidence that the reported failure mode could not be duplicated, the most probable root cause is due to user error. All sss's reprocessed cardiac stabilization devices are 100% function tested and inspected before leaving sss. The reported event is not occurring more frequently or with greater severity than is usual for the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2090040-2011-00013 |
| MDR Report Key | 2193548 |
| Report Source | 05,06,07 |
| Date Received | 2011-08-05 |
| Date of Report | 2011-07-12 |
| Date of Event | 2011-07-12 |
| Date Mfgr Received | 2011-07-12 |
| Date Added to Maude | 2011-08-08 |
| 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 | MS. MOIRA BARTON-VARTY |
| Manufacturer Street | 10232 S 51ST STREET |
| Manufacturer City | PHOENIX AZ 85044 |
| Manufacturer Country | US |
| Manufacturer Postal | 85044 |
| Manufacturer Phone | 4807635300 |
| Manufacturer G1 | STRYKER SUSTAINABILITY SOLUTIONS |
| Manufacturer Street | 10232 S. 51ST STREET |
| Manufacturer City | PHOENIX AZ 85044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A |
| Generic Name | NQG |
| Product Code | NQG |
| Date Received | 2011-08-05 |
| Returned To Mfg | 2011-07-25 |
| Model Number | 29403-K |
| Catalog Number | 29403-K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS |
| Manufacturer Address | 10232 S. 51ST STREET PHOENIX AZ 85044 US 85044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-05 |