MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2009-02-26 for STONETOME REMOVAL DEVICE M00535190 3519 manufactured by Boston Scientific Corporation.
[1052972]
A stonetome device was used during a procedure. According to the complainant, a cannula was placed to the papilla and 0. 035inch jagwire was crossed to the lesion. When this device was advanced to the lesion and an attempt was made to cut, a bend was noted at the blade and the device was removed from the patient's body. The procedure was completed with another of the same device. There were no patient complications reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[8187802]
As received, it was found that exposed cutting wire was bent, confirming the customer complaint. It appears that the tension of the cutting wire was not set right during the handle assembly (manufacturing). The cutting wire could have been bent due to a combination of subsequent manufacturing/ packaging operations, setting of the tome in the tray/ package and the effect of sterilization or during customer usage/prepping due to the lack of tension/too much slack in the cutting wire. A device history record review of lot number 11542650 was performed and revealed no issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-05722 |
| MDR Report Key | 1326423 |
| Report Source | 00,01,05 |
| Date Received | 2009-02-26 |
| Date of Report | 2008-07-17 |
| Date of Event | 2008-07-14 |
| Date Mfgr Received | 2008-07-17 |
| Device Manufacturer Date | 2008-03-13 |
| Date Added to Maude | 2009-02-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEN HIRAKAWA |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| 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 | STONETOME REMOVAL DEVICE |
| Generic Name | SPHINCTEROTOME |
| Product Code | ODD |
| Date Received | 2009-02-26 |
| Returned To Mfg | 2008-08-02 |
| Model Number | M00535190 |
| Catalog Number | 3519 |
| Lot Number | 0011542650 |
| Device Expiration Date | 2009-03-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 780 BROOKSIDE DRIVE SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-26 |