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 |