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 2019-04-03 for STONETOME M00535150 3515 manufactured by Boston Scientific Corporation.
[140744250]
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18. (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
[140744251]
It was reported to boston scientific corporation that a stonetome was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019. According to the complainant, during the procedure, after viewing the papilla with a scope, this device was advanced along the guidewire. When the handle was pulled to incise the papilla, it was noticed that the cutting wire broke. Reportedly, the broken cutting wire remained attached to the device and no part detached inside the patient. The procedure was completed with a second stonetome, using the same generator and active cord used to complete the procedure. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01624 |
| MDR Report Key | 8477742 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-03 |
| Date of Report | 2019-05-06 |
| Date of Event | 2019-03-08 |
| Date Mfgr Received | 2019-04-15 |
| Device Manufacturer Date | 2018-10-05 |
| Date Added to Maude | 2019-04-03 |
| 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 DE COSTA RICA S.R.L. |
| Manufacturer Street | 2546 CALLE PRIMERA PROPARK, COYOL |
| 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 | 2019-04-03 |
| Returned To Mfg | 2019-03-20 |
| Model Number | M00535150 |
| Catalog Number | 3515 |
| Lot Number | 0022704043 |
| 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 | 2019-04-03 |