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 2020-03-30 for JETSTREAM XC 45007 manufactured by Boston Scientific Corporation.
[185666064]
Age at time of event: patient is over 18 years old.
Patient Sequence No: 1, Text Type: N, H10
[185666065]
It was reported that the device became stuck on the wire. A 2. 4mm jetstream xc catheter was selected for an atherectomy procedure in the superficial femoral artery (sfa) for a lesion with over 85% stenosis and more than 95% calcification. The atherectomy was completed without issue. However, upon removal while the device was in rex mode, it became stuck on a non-bsc filter wire. No patient complications were reported and the patient was fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-04000 |
| MDR Report Key | 9898136 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-11-18 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| Returned To Mfg | 2020-03-25 |
| Model Number | 45007 |
| Catalog Number | 45007 |
| Lot Number | 0024788362 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-30 |