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 2020-03-03 for REBEL 10289 manufactured by Boston Scientific Corporation.
[182211315]
Device evaluated by mfr: returned product consisted of a rebel bms stented catheter. The balloon was loosely folded. The stent was is on the balloon. The hypotube, outer shaft, inner shaft, balloon, stent and tip were visually and microscopically examined. The distal end of the stent is stretched/damaged. There are numerous hypotube and shaft kinks. Inspection of the remainder of the device presented no other damage or irregularities. There was no evidence of any damage or irregularities contributing to the reported difficulty, which could not be confirmed because the clinical circumstances could not be replicated.
Patient Sequence No: 1, Text Type: N, H10
[182211316]
Reportable based on device analysis completed on 26feb2020. It was reported that unable to cross lesion occurred. The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified internal carotid artery. A 24 x 4. 50 rebel stent balloon was advanced for dilation but failed to cross lesion. No further patient complications reported. However, returned device analysis revealed stent damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02459 |
| MDR Report Key | 9779358 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2018-04-24 |
| Date Added to Maude | 2020-03-03 |
| 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 CORPORATION |
| 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 | REBEL |
| Generic Name | STENT, CORONARY |
| Product Code | MAF |
| Date Received | 2020-03-03 |
| Returned To Mfg | 2020-02-04 |
| Model Number | 10289 |
| Catalog Number | 10289 |
| Lot Number | 0022034164 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-03 |