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 2006-05-23 for ULTRAFLEX ESOPHAGEAL STENT * 1303 manufactured by Boston Scientific Corp.
[448976]
A pt underwent a therapeutic placement of an esophageal stent. When the ultraflex esophageal stent was approiximately 50% deployed, the deployment suture broke. The delivery catheter was cut and the stent was able to be fully deployed. The stent was successfully deployed. The pt did not sustain any complications or ill effect as a result of the brekage of the deployment suture. The pt condition is reported to be 'ok'.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000050-2006-00059 |
| MDR Report Key | 718645 |
| Report Source | 01,05,06,07 |
| Date Received | 2006-05-23 |
| Date of Report | 2006-04-26 |
| Date of Event | 2006-04-26 |
| Date Mfgr Received | 2006-04-26 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2006-05-26 |
| 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 | NANCY CUTINO |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760 |
| Manufacturer Phone | 5086834066 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORP |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRAFLEX ESOPHAGEAL STENT |
| Generic Name | METAL STENT |
| Product Code | FGF |
| Date Received | 2006-05-23 |
| Model Number | * |
| Catalog Number | 1303 |
| Lot Number | 8033963 |
| ID Number | * |
| Device Expiration Date | 2008-09-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 707713 |
| Manufacturer | BOSTON SCIENTIFIC CORP |
| Manufacturer Address | BALLYBRIT BUSINESS PARK GALWAY EI |
| Baseline Brand Name | UNCOVERED ESOPHAGEAL STENT |
| Baseline Generic Name | ESOPHAGEAL STENT |
| Baseline Model No | NA |
| Baseline Catalog No | 1303 |
| Baseline ID | NA |
| Baseline Device Family | ESOPHAGEAL STENT |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K955347 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-23 |