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 2020-01-24 for TRAPEZOID RX M00510860 1086 manufactured by Boston Scientific Corporation.
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(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
[176247177]
It was reported to boston scientific corporation that a trapezoid rx basket was used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019. According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid basket in an attempt to crush a stone. However, the handle cannula broke during the attempt, entrapping the stone inside the basket and causing the basket to become stuck inside the patient's biliary duct. The catheter was cut at the basket handle and the scope was removed from the patient. The stone and basket remained in the bile duct and the patient was referred to another hospital. Reportedly, the condition of the patient at the conclusion of the procedure was stable, however, a few days after a bile drain tube insertion, the patient passed away. The basket remained in the patient at the time of the patient's death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00107 |
| MDR Report Key | 9627350 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-24 |
| Date of Report | 2020-02-18 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2019-04-12 |
| Date Added to Maude | 2020-01-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2020-01-24 |
| Model Number | M00510860 |
| Catalog Number | 1086 |
| Lot Number | 0023638740 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Death | 2020-01-24 |