MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for TRAPEZOID RX M00510880 manufactured by Boston Scientific.
[175061345]
A (b)(6) y/o female was admitted with common bile duct stones. Pt went to the endoscopy unit for an ercp due to the stones. The trapezoid basket was used to entrap, crush, and remove stones. The basket was placed in alliance ii cre gun to crust the stone. The wire basket broke while in the common bile duct. Emergency coil and handle were used per instructions to remove the basket but this was unsuccessful. The gastroenterologist discussed the complication with the on-call surgeon who stated he doesn't perform common bile duct exploration. The decision was made to transfer the patient to another facility for removal of the wire basket and cholecystectomy with bile duct exploration. The patient was transferred to the icu. She remained intubated due to being a difficult intubation. The wire used for the procedure was left coming out of the patient's mouth and was taped to the side of the bed. She was transferred to another facility later that night. The ercp was noted to be technically difficult and complex due to a large stone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9586999 |
| MDR Report Key | 9586999 |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-07 |
| Date of Event | 2020-01-01 |
| Date Facility Aware | 2020-01-02 |
| Report Date | 2020-01-07 |
| Date Added to Maude | 2020-01-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRAPEZOID RX |
| Generic Name | TRAPEZOID RX |
| Product Code | LQC |
| Date Received | 2020-01-08 |
| Catalog Number | M00510880 |
| Lot Number | 24593053 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-01-08 |