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 2020-02-28 for JETSTREAM XC 45007 manufactured by Boston Scientific Corporation.
[181422717]
It was reported that the catheter became stuck on the guidewire. A 2. 1mm jetstream xc catheter was selected for an atherectomy procedure in the left superficial femoral artery (sfa). Atherectomy was performed and then the procedure was stopped to pull some blood for an activated clotting time (act). Following the act, an attempt was made to activate the device again; however the device did not activate. No error message displayed. The whole system was removed from the patient as the guidewire would not move in and out of the catheter. The procedure was completed with a balloon and stent. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02201 |
| MDR Report Key | 9769452 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2019-10-09 |
| Date Added to Maude | 2020-02-28 |
| 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 IRELAND |
| Manufacturer Country | EI |
| Manufacturer Postal Code | IRELAND |
| 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 | 2020-02-28 |
| Model Number | 45007 |
| Catalog Number | 45007 |
| Lot Number | 0024570150 |
| 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 | 2020-02-28 |