MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-05-27 for DYNAMIC Y STENT M00570690 manufactured by Boston Scientific Corporation- Marlborough.
[20939708]
During the procedure the stent would not properly deploy. The physician removed the stent and aborted the procedure and the patient is now on a ventilator and unable to breath on his own. The patient's condition was reported as "stable. "
Patient Sequence No: 1, Text Type: D, B5
[21207275]
The device has been disposed of by the user facility. An evaluation cannot be performed; therefore a failure analysis is not available. Product disposed
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-02656 |
| MDR Report Key | 1393088 |
| Report Source | 05,07 |
| Date Received | 2009-05-27 |
| Date of Report | 2008-03-10 |
| Date of Event | 2008-03-10 |
| Date Mfgr Received | 2008-03-10 |
| Date Added to Maude | 2009-05-27 |
| 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 | CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836132 |
| Manufacturer G1 | WILLY RUSCH GMBH |
| Manufacturer Street | P.O. BOX 1180 |
| Manufacturer City | KERNEN, 71385 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 71385 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNAMIC Y STENT |
| Generic Name | NYT |
| Product Code | NYT |
| Date Received | 2009-05-27 |
| Model Number | M00570690 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2009-05-27 |