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 2020-03-02 for JETSTREAM XC 45007 manufactured by Boston Scientific Corporation.
[181825171]
Age at time of event: (b)(6). Device evaluated by manufacturer: visual examination of the shaft and remainder of the device showed damage in the form of 1 kink located 6. 5cm from the tip. There was buckling/kinking located 1. 5cm from the tip. The functionality of the device was checked by setting up the product per the directions for use. The device primed as designed. The device was functionally tested, and the device did not rotate as designed. No errors were noticed on the console. Inspection of the remainder of the device, apart from the observed damage revealed no damage or irregularities.
Patient Sequence No: 1, Text Type: N, H10
[181825172]
It was reported that the device had a loss of rotation. A 2. 4mm jetstream xc catheter was selected for atherectomy procedure in the left superficial femoral artery (sfa). During the procedure, the device advanced further down to the sfa. As the device was advancing proximal popliteal area, the device stalled and the device lost rotation. It did not show any error message. The physician decided to run it again but it did not work. The rex would not engage or advance. The device was removed manually from the patient and the procedure was completed successfully by a balloon angioplasty and another stents. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02365 |
| MDR Report Key | 9774205 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2019-05-08 |
| Date Added to Maude | 2020-03-02 |
| 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 CORK LIMITED |
| 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 | 2020-03-02 |
| Returned To Mfg | 2020-02-19 |
| Model Number | 45007 |
| Catalog Number | 45007 |
| Lot Number | 0023758299 |
| 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 | 2020-03-02 |