MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-27 for SPYSCOPE DS M00546600 4660 manufactured by Boston Scientific Corporation.
[137292423]
(b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[137292424]
It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the biliary duct during a cholangioscopy procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the spyscope ds lost visualization. A second spyscope ds was opened and inserted over a jagwire guidewire into the bile duct. They had good visualization; however, the working channel sleeve of the second spyscope ds suddenly protruded and hit the biliary tree which caused a minor bleed. Reportedly, there was no medical intervention required to address the bleed. The procedure was completed with a third spyscope digital access and delivery catheter. The patient's condition at the end of the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-00992 |
| MDR Report Key | 8374872 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-27 |
| Date of Report | 2019-05-15 |
| Date of Event | 2019-02-05 |
| Date Mfgr Received | 2019-04-23 |
| Device Manufacturer Date | 2018-10-02 |
| Date Added to Maude | 2019-02-27 |
| 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 | 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 | 2019-02-27 |
| Model Number | M00546600 |
| Catalog Number | 4660 |
| Lot Number | 22732214 |
| 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 | 2019-02-27 |