MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-02-26 for STENT REMOVAL ACCESSORY M0061801001 180-100 manufactured by Boston Scientific Corporation-spencer.
[1066858]
During preparation they found the device was split out of the package. The physician completed the procedure with another stent removal device with no patient complications, and the patient is fine.
Patient Sequence No: 1, Text Type: D, B5
[8180621]
A visual inspection of the returned device found the distal tip of the sheath is split. There is a 12 mm long split in the tip of the sheath. The split has allowed one of three prongs of the device to open up and not close with the other two prongs when the handle is functioned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-05606 |
| MDR Report Key | 1326241 |
| Report Source | 05,07 |
| Date Received | 2009-02-26 |
| Date of Report | 2008-06-17 |
| Date of Event | 2008-06-16 |
| Date Mfgr Received | 2008-06-17 |
| Device Manufacturer Date | 2006-05-30 |
| Date Added to Maude | 2009-06-23 |
| 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 | GEORGE FEDOR |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836415 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION-SPENCER |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STENT REMOVAL ACCESSORY |
| Generic Name | KOA |
| Product Code | KOA |
| Date Received | 2009-02-26 |
| Returned To Mfg | 2008-06-27 |
| Model Number | M0061801001 |
| Catalog Number | 180-100 |
| Lot Number | 0008699434 |
| Device Expiration Date | 2010-05-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION-SPENCER |
| Manufacturer Address | 780 BROOKSIDE DRIVE SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-26 |