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 2020-02-19 for TRAPEZOID RX M00510880 1088 manufactured by Boston Scientific Corporation.
[181751318]
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. (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 mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[181751319]
It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020. According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid basket in attempt to crush a stone. However, the basket failed to crush the stone. Moreover, the thumb ring bent as they continue to attempt to crush the stone and the tip failed to detach. A hurricane rx biliary balloon dilatation catheter was inserted to cannulate the bile duct and dilate the orifice to remove the basket with stone out of the patient. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00440 |
| MDR Report Key | 9727811 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-02-19 |
| 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 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 | TRAPEZOID RX |
| Generic Name | LITHOTRIPTOR, BILIARY MECHANICAL |
| Product Code | LQC |
| Date Received | 2020-02-19 |
| Model Number | M00510880 |
| Catalog Number | 1088 |
| 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 | 1. Required No Informationntervention | 2020-02-19 |