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 2020-03-17 for JETSTREAM XC 45007 manufactured by Boston Scientific Corporation.
[183878360]
(b)(6). Device evaluated by manufacturer: returned product consisted of a jetstream xc-2. 1 atherectomy catheter. Visual examination noticed that the infusion, electrical and baton were cut from the pod. With this damage functionality of the device could not be confirmed. It was noticed that there was shaft damage in the form of buckling/kinks located 4cm and 80. 5cm from the tip. Microscope examination noticed that the infusion line had burst proximal the buckling/kinks. The location of the burst infusion line was approximately 89cm to 91cm from the tip. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Patient Sequence No: 1, Text Type: N, H10
[183878361]
It was reported that the device fell apart and leaked. A 2. 1mm jetstream xc catheter was selected for an atherectomy procedure in the severely calcified right superficial femoral artery (sfa). The physician noticed that the shaft of the catheter started to fall apart and leak towards the end of the procedure. The procedure was completed successfully with this device. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03235 |
| MDR Report Key | 9841771 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-07-08 |
| Date Added to Maude | 2020-03-17 |
| 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 | 2020-03-17 |
| Returned To Mfg | 2020-03-10 |
| Model Number | 45007 |
| Catalog Number | 45007 |
| Lot Number | 0024066237 |
| 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 | 2020-03-17 |