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 2020-03-03 for STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PRD-SC30-MICRO 7-10059-01 manufactured by Cardiovascular Systems, Inc..
[181817303]
The reported oad was received for analysis. Adhered biological material was observed on the crown of the oad. Examination of the area of adhered material did not reveal any damage. The morphology and root cause of the biological material was unknown. No damage to the driveshaft or crown that could have contributed to the perforation was observed. A guide wire was passed through the area of adhered material with no resistance. The oad spun at all speeds and functioned as intended. The data logs of the oad showed that a motor stall occurred. At the conclusion of the device analysis, the reported event of a perforation was unable to be conclusively confirmed. The log report of an oad stall may have been related to the event of the oad slowing down, however, this was unable to be conclusively confirmed. The device history record for this oad lot number has been reviewed. No issues or discrepancies were noted during this review that would have contributed to the reported event. The device met material, assembly, and quality control requirements. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[181817304]
During a procedure with a stealth peripheral orbital atherectomy device (oad), a perforation occurred. The 100% occluded, heavily calcified lesion was located along the entire length of the posterior tibial artery (pt) and was treated on medium speed with the oad. The oad started to lose power and perforation occurred. The perforation was treated with balloon tamponade, and the procedure was delayed by greater than thirty (30) minutes. Pain medications were administered to the patient, a blood pressure cuff was applied. The patient was stable following the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004742232-2020-00061 |
| MDR Report Key | 9781622 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2019-08-28 |
| Date Added to Maude | 2020-03-03 |
| 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 | SARAH HICKS |
| Manufacturer Street | 1225 OLD HIGHWAY 8 NW |
| Manufacturer City | SAINT PAUL, MN |
| Manufacturer Country | US |
| Manufacturer G1 | CARDIOVASCULAR SYSTEMS, INC. |
| Manufacturer Street | 1225 OLD HIGHWAY 8 NW |
| Manufacturer City | SAINT PAUL, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM |
| Generic Name | PERIPHERAL ATHERECTOMY DEVICE |
| Product Code | MCW |
| Date Received | 2020-03-03 |
| Returned To Mfg | 2020-02-13 |
| Model Number | PRD-SC30-MICRO |
| Catalog Number | 7-10059-01 |
| Lot Number | 287247 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIOVASCULAR SYSTEMS, INC. |
| Manufacturer Address | 1225 OLD HIGHWAY 8 NW SAINT PAUL, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-03 |