MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-03 for SPYSCOPE DS M00546600 4660 manufactured by Boston Scientific Corporation.
[140771942]
The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown. (b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[140771943]
It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was prepared and was intended to be used in the pancreaticobiliary system for a cholangioscopy procedure on (b)(6) 2019. According to the complainant, during preparation, it was noticed that the sterile barrier of the spyscope ds was compromised. The device was considered unsterile. Reportedly, there was no visible damage noticed with the spyscope ds. A new device was unpacked and the procedure was completed with a second spyscope digital access and delivery catheter. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01634 |
| MDR Report Key | 8478438 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-03 |
| Date of Report | 2019-04-03 |
| Date of Event | 2019-03-13 |
| Date Mfgr Received | 2019-03-13 |
| Date Added to Maude | 2019-04-03 |
| 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 | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| 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 | SPYSCOPE DS |
| Generic Name | CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID |
| Product Code | FBN |
| Date Received | 2019-04-03 |
| Model Number | M00546600 |
| Catalog Number | 4660 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-03 |