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 2019-04-24 for STONETOME M00535150 3515 manufactured by Boston Scientific Corporation.
[143040618]
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. (date of event): the exact date of the event is unknown. The provided event date (b)(6) 2019 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). 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
[143040619]
It was reported to boston scientific corporation that a stonetome was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure. According to the complainant, during the procedure, the stonetome was inserted into the papilla. The physician tried to perform incision but the cut wire was oriented in the wrong direction and could not be directed to the 11 o'clock direction. The stonetome was manipulated by any means; however, it did not turn towards the 11 o'clock direction. Reportedly, there was no visible damage to the device prior to putting it through the scope or after the issue occurred. The procedure was completed with a second stonetome. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02187 |
| MDR Report Key | 8546577 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-24 |
| Date of Report | 2019-06-06 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-05-15 |
| Date Added to Maude | 2019-04-24 |
| 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 | 2019-04-24 |
| Returned To Mfg | 2019-04-16 |
| Model Number | M00535150 |
| Catalog Number | 3515 |
| 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 | 2019-04-24 |