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 2020-02-11 for SPYSCOPE DS M00546600 4660 manufactured by Boston Scientific Corporation.
[188648479]
The exact date of the event is unknown. The provided event date (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event. 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
[188648480]
It was reported to boston scientific corporation that a spyscope ds was used in the liver and pancreas during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on an unknown date. Reportedly, there were no issues noted with the spyscope ds during the procedure. According to the complainant, post procedure, the patient developed a fistula in the liver. On an unknown date, the patient went back to the hospital for placement of percutaneous drainage; subsequently, the drainage was removed and patient was discharged. On an unknown date, the patient came back to hospital for a polyp procedure in which a wallflex biliary rx fully covered rmv stent was implanted. Post stent placement, the patient had cholecystitis and was hospitalized. On an unknown date, the patient underwent a surgery for the pancreatic mass. Per the physician, the patient had a bad pancreatic cancer. The patient's condition following the surgery was reported to be stable. Note: despite efforts, boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date. Should additional relevant details become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00376 |
| MDR Report Key | 9694814 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-02-11 |
| 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 | 2020-02-11 |
| 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 | 1. Required No Informationntervention | 2020-02-11 |