MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05,07 report with the FDA on 2009-05-27 for SPYGLASSTM DIRECT VISUALIZATION PROBE M00546030 4603 manufactured by Boston Scientific Corporation- Marlborough.
[1158261]
The complainant reported that a mal patient with a distal common bile duct stricture had undergone two previous therapeutic ercp procedures, and had a pre-existing condition of cholangitis (< 4 weeks). The patient was then seen for an additional spyglass dvs procedure in 2007. After the ercp and then the spyglass procedure on the same day, the patient had a fever and abdominal pain and was admitted to the hospital. The patient was then observed in the hospital for 24 hours and was then discharged and prescribed antibiotics. The severity was noted as "mild".
Patient Sequence No: 1, Text Type: D, B5
[8456947]
The lot number is unknown; therefore, the manufacture and expiration dates cannot be determined. The complainant reported that the device was discarded subsequent to use; therefore, a device evaluation is not available. The relationship between the suspect device and the reported event is undetermined. Device not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-02881 |
| MDR Report Key | 1392930 |
| Report Source | 02,05,07 |
| Date Received | 2009-05-27 |
| Date of Report | 2007-06-01 |
| Date of Event | 2007-05-29 |
| Date Mfgr Received | 2007-06-01 |
| 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 | MYRIAD FIBER IMAGING TECHNOLOGIES, INC. |
| Manufacturer Street | 6 SOUTHBRIDGE ROAD |
| Manufacturer City | DUDLEY MA 01571 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01571 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPYGLASSTM DIRECT VISUALIZATION PROBE |
| Generic Name | ENDOSCOPE AND ACCESSORIES |
| Product Code | ODF |
| Date Received | 2009-05-27 |
| Model Number | M00546030 |
| Catalog Number | 4603 |
| Lot Number | UNK |
| 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. Required No Informationntervention | 2009-05-27 |