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 2020-03-23 for STEALTH ORBITAL ATHERECTOMY SYSTEM PRD-SC30-200 70056-06 manufactured by Cardiovascular Systems, Inc..
[184442303]
Analysis of the reported device is in progress. A supplemental report will be submitted when the device analysis is completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184442304]
A stealth orbital atherectomy device (oad) was selected for treatment in the common femoral artery via 6fr access. The driveshaft of the oad broke during an attempt to advance the oad over the bifurcation. A competitor catheter was inserted in order to pull the guide wire and fragment of oad into the sheath and out of the patient. The procedure was completed with a smaller oad and angioplasty with excellent results and minimal delay. The patient was stable and was discharged without complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004742232-2020-00093 |
| MDR Report Key | 9864873 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-10-16 |
| Date Added to Maude | 2020-03-23 |
| 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 | MORGAN HILL |
| Manufacturer Street | 1225 OLD HWY 8 NW |
| Manufacturer City | ST. PAUL, MN |
| Manufacturer Country | US |
| Manufacturer G1 | CARDIOVASCULAR SYSTEMS, INC. |
| Manufacturer Street | 1225 OLD HWY 8 NW |
| Manufacturer City | ST. PAUL, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STEALTH ORBITAL ATHERECTOMY SYSTEM |
| Generic Name | PERIPHERAL ORBITAL ATHERECTOMY DEVICE |
| Product Code | MCW |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-03-04 |
| Model Number | PRD-SC30-200 |
| Catalog Number | 70056-06 |
| Lot Number | 293922 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIOVASCULAR SYSTEMS, INC. |
| Manufacturer Address | 1225 OLD HWY 8 NW ST. PAUL, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-23 |