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 2020-03-13 for JETSTREAM XC 45007 manufactured by Boston Scientific Corporation.
[183317343]
Device evaluated by manufacturer. The device was visually examined for any shaft damage. Visual examination noticed that there was shaft damage in the form of buckling/kinks located 1. 5cm proximally to 11cm from the tip. Visual examination noticed that the infusion line had burst proximal the buckling/kinks. The location of the burst infusion line was approximately 12cm to 13. 5cm from the tip. The device was set-up and functionally tested per the directions for use and the device functioned as designed except for the leaking at the burst infusion line. The rex functioned was as designed. 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
[183317344]
It was reported that the infusion line bubbled and was unable to be further used. A 2. 4mm jetstream xc catheter was selected for use in an atherectomy procedure. During the procedure, the outer casing of the catheter became bubbled and was unable to be used. There was no harm to the patient and no complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03168 |
| MDR Report Key | 9830041 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2020-01-10 |
| Date Added to Maude | 2020-03-13 |
| 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 | 2020-03-13 |
| Returned To Mfg | 2020-03-06 |
| Model Number | 45007 |
| Catalog Number | 45007 |
| Lot Number | 0025018332 |
| 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 | 2020-03-13 |