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 2019-05-22 for EXPRESS SD RENAL/BILIARY 20188 manufactured by Boston Scientific Corporation.
[145832137]
It was reported that shaft break occured. The target lesion was located in the left renal artery. A 6. 0mmx18mmx150cm express sd renal/biliary drug-eluting stent was advanced for treatment. However, during procedure, it was noted that they tried to advanced the stent but it would not deploy. The device broke inside the patient's body but they successfully removed it. The procedure ws completed with a different device. There were no patient complications nor injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-05587 |
| MDR Report Key | 8632978 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-22 |
| Date of Report | 2019-07-23 |
| Date of Event | 2019-01-21 |
| Date Mfgr Received | 2019-07-14 |
| Device Manufacturer Date | 2018-09-10 |
| Date Added to Maude | 2019-05-22 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC SCIMED, INC |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXPRESS SD RENAL/BILIARY |
| Generic Name | CATHETER, BILIARY, DIAGNOSTIC |
| Product Code | NIN |
| Date Received | 2019-05-22 |
| Returned To Mfg | 2019-06-21 |
| Model Number | 20188 |
| Catalog Number | 20188 |
| Lot Number | 0022631407 |
| 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 | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-22 |