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 2020-03-11 for JETSTREAM XC 45007 manufactured by Boston Scientific Corporation.
[183100509]
Age at time of event: patient is over 18 years old.
Patient Sequence No: 1, Text Type: N, H10
[183100510]
It was reported that the device stopped spinning. A jetstream xc catheter, 2. 4mm was selected for a lower extremity atherectomy procedure. During the procedure, the device stopped spinning while engaged in the plaque. The sound abruptly changed when the issue occurred. The device was safely removed and the procedure was completed successfully by a balloon angioplasty and stent placement. No patient complications were reported and there were no adverse effects regarding the patient. The patient was fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02859 |
| MDR Report Key | 9818392 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-10-09 |
| Date Added to Maude | 2020-03-11 |
| 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 | MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JETSTREAM XC |
| Generic Name | CATHETER, PERIPHERAL, ATHERECTOMY |
| Product Code | MCW |
| Date Received | 2020-03-11 |
| Model Number | 45007 |
| Catalog Number | 45007 |
| Lot Number | 0024570151 |
| 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 | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |