MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-11-11 for DYNAMIC (Y) STENT M00570680 7068 manufactured by Boston Scientific Corporation.
[965848]
It was reported to boston scientific corp that a dynamic (y) stent device was being placed in a rigid bronchoscopy procedure of the trachea in 2008 (female pt; weight unk). According to the complainant, during the procedure, "the stent fractured and ripped in half. " it was further reported that the stent was removed and the pt was intubated; the procedure was not completed due to this event. There were no pt complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[8227599]
Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-06194 |
| MDR Report Key | 1226530 |
| Report Source | 05,07 |
| Date Received | 2008-11-11 |
| Date of Report | 2008-10-14 |
| Date of Event | 2008-10-14 |
| Date Mfgr Received | 2008-10-14 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2008-11-17 |
| 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 | KEN HIRAKAWA |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836264 |
| Manufacturer G1 | WILLY RUSCH GMBH, TELEFLEX MEDICAL |
| Manufacturer Street | WILLY RUSCH STRASSE 4-10 |
| Manufacturer City | KERNEN I.R. 71394 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 71394 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNAMIC (Y) STENT |
| Product Code | NYT |
| Date Received | 2008-11-11 |
| Returned To Mfg | 2008-10-30 |
| Model Number | M00570680 |
| Catalog Number | 7068 |
| Lot Number | 000008071 |
| ID Number | NA |
| Device Expiration Date | 2013-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1281322 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-11-11 |