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 2019-04-16 for STONETOME M00535190 3519 manufactured by Boston Scientific Corporation.
[142128959]
(b)(4). The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[142128960]
Note: this report pertains to the second of two devices used during the same procedure. It was reported to boston scientific corporation that a stonetome was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019. According to the complainant, during the procedure, when the nurse attempted to bow the device, it was noticed that the cut wire was oriented in the wrong direction which was reportedly pointing at 6 o'clock direction. It remained unusable as the orientation could not be corrected. A second stonetome was used but same thing happened. Reportedly, there was no tortuous anatomy impacting scope positioning and no visible damage to the devices prior to putting it through the scope or after the issue occurred. The procedure was completed with the different device. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01955 |
| MDR Report Key | 8519485 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-16 |
| Date of Report | 2019-04-16 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-03-27 |
| Device Manufacturer Date | 2018-07-30 |
| Date Added to Maude | 2019-04-16 |
| 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 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 | 2019-04-16 |
| Model Number | M00535190 |
| Catalog Number | 3519 |
| Lot Number | 0022349247 |
| 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 | 2019-04-16 |