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 2019-05-01 for SPYSCOPE DS M00546600 4660 manufactured by Boston Scientific Corporation.
[143814107]
The patient was born in (b)(6). (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
[143814108]
It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the bile duct during a cholangioscopy procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the spyscope ds was inserted into the bile duct via a guidewire. They were able to push the device to the stenosis without resistance. When the guidewire was removed, the physician noticed that the working channel sleeve of the spyscope ds protruded. The spyscope ds was removed and replaced with a new one. The procedure was completed with the same original guidewire and the second spyscope digital access and delivery catheter. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02323 |
| MDR Report Key | 8570771 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-01 |
| Date of Report | 2019-08-08 |
| Date of Event | 2019-04-02 |
| Date Mfgr Received | 2019-07-10 |
| Device Manufacturer Date | 2018-08-20 |
| Date Added to Maude | 2019-05-01 |
| 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 | 2019-05-01 |
| Returned To Mfg | 2019-05-24 |
| Model Number | M00546600 |
| Catalog Number | 4660 |
| Lot Number | 0022537583 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-01 |