MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-03-23 for STONETOME M00535110 3511 manufactured by Boston Scientific Corporation.
[188527923]
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, (b)(6) 2020. (b)(4). The device has been received for analysis; however, the analysis has not yet been completed. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[188527924]
It was reported to boston scientific corporation that a stonetome device was used in the papilla during an endoscopic sphincterotomy (est) procedure performed on an unknown date. According to the complainant, during the procedure, the cutting wire was facing in the direction of 13 o'clock and could not be directed to the 11 o'clock direction. The procedure was completed with another stonetome device. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00720 |
| MDR Report Key | 9867937 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-06-27 |
| Date Added to Maude | 2020-03-23 |
| 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 | 2546 CALLE PRIMERA |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STONETOME |
| Generic Name | DISLODGER, STONE, BILIARY |
| Product Code | LQR |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-03-12 |
| Model Number | M00535110 |
| Catalog Number | 3511 |
| Lot Number | 0024023253 |
| 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 | 2020-03-23 |