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 2020-01-06 for TRAPEZOID RX M00510880 1088 manufactured by Boston Scientific Corporation.
[173849047]
(b)(4). The device has not been received for analysis. Upon receipt and 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
[173849048]
It was reported to boston scientific corporation that a trapezoid rx basket was used during a stone extraction procedure on (b)(6) 2019. According to the complainant, during the procedure, a trapezoid basket was used in an attempt to remove a stone. However, the pull wire broke during lithotripsy. A biopsy forceps was used to remove the stone from the basket, a grasper was used to remove the trapezoid basket and two stents were placed. Reportedly, the patient experienced retropneumoperitoneum post procedure due to the difficulty in completing the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-06379 |
| MDR Report Key | 9555721 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-06 |
| Date of Report | 2020-03-17 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-10-08 |
| Date Added to Maude | 2020-01-06 |
| 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 | 2020-01-06 |
| Returned To Mfg | 2020-01-22 |
| Model Number | M00510880 |
| Catalog Number | 1088 |
| Lot Number | 0024561769 |
| 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 | 1. Required No Informationntervention | 2020-01-06 |