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 2019-03-04 for SPYSCOPE DS M00546600 4660 manufactured by Boston Scientific Corporation.
[137799585]
The date has been chosen based upon the approximated date provided by the complainant. (b)(4). Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon 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
[137799586]
Note: this report pertains to one of two hurricane rx dilatation balloons and a spyscope digital access and delivery catheter used in the same patient and procedure. It was reported to boston scientific corporation that a spyscope digital access and delivery catheter and two hurricane rx dilatation balloons were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date. According to the complainant, during the procedure, the working channel sleeve protruded. Reportedly, no accessory device was inside the spyscope ds when the working channel sleeve protruded. A hurricane rx dilatation balloon was also used and the balloon burst. The same issue occurred with the second hurricane balloon. The procedure was completed with another hurricane rx dilatation balloon and 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 | 3005099803-2019-01042 |
| MDR Report Key | 8388458 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-04 |
| Date of Report | 2019-04-05 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-03-14 |
| Device Manufacturer Date | 2018-09-26 |
| Date Added to Maude | 2019-03-04 |
| 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 | 2019-03-04 |
| Returned To Mfg | 2019-02-19 |
| Model Number | M00546600 |
| Catalog Number | 4660 |
| Lot Number | 22710968 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-03-04 |