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 2020-01-16 for SPYSCOPE DS II ACCESS & DELIVERY CATHETER M00546610 1759-02 manufactured by Boston Scientific Corporation.
[175257730]
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
[175257731]
Note: this report pertains to a spyscope ds ii, spybite, and jagwire used during the same procedure. Refer to manufacturer report# 3005099803-2020-00069 and 3005099803-2020-00068 for the other associated device information. It was reported to boston scientific corporation that a spyscope ds ii, spybite, jagwire revolution and a non-bsc sphincterotome were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) and cholangioscopy procedure performed on (b)(6) 2019. According to the complainant, after the procedure, the patient suffered an air embolism which was suspected to be caused by a perforation. The physician could not confirm if the perforation was related to the spyscope, spybite, guidewire, or non-bsc sphincterotome. Boston scientific has been unable to obtain additional information regarding the cause of the perforation to date, despite good faith efforts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00067 |
| MDR Report Key | 9596109 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2020-01-03 |
| Date Added to Maude | 2020-01-16 |
| 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 II ACCESS & DELIVERY CATHETER |
| Generic Name | CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID |
| Product Code | FBN |
| Date Received | 2020-01-16 |
| Model Number | M00546610 |
| Catalog Number | 1759-02 |
| 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 | 2020-01-16 |