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 2020-03-12 for DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM DBEC-125 70058-13 manufactured by Cardiovascular Systems, Inc..
[183108212]
The oad was received for analysis. Adhered, dried blood was embedded in the driveshaft. Examination of the area of the adhered material did not reveal any damage that would have contributed to the material accumulation. The exact root cause of the material accumulation is unknown. A guide wire passed through the driveshaft and oad handle, including the area of embedded material, with no resistance. The oad spun on all speeds and functioned as intended. At the conclusion of the device analysis, the reported events of vessel spasm, dissection, and no flow were unable to be conclusively confirmed through analysis. 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
[183108213]
During a procedure with a diamondback coronary orbital atherectomy device (oad), one treatment pass was completed on low speed for a 90%, severely calcified lesion in the mid-circumflex artery. The patient's circumflex and left anterior descending coronary artery spasmed, and there was no flow in the circumflex. A type f dissection occurred. The patient began to decompensate, and the circumflex was ballooned and stented. Imaging performed after angioplasty and stent deployment showed the vessel was open with a good treatment result. During angioplasty and stent deployment, the patient's heart rate and blood pressure could not be maintained; vasopressors were administered, and the patient was intubated. After stent deployment an intra-aortic balloon pump (iabp) was inserted. The patient was extubated on (b)(6) 2020, and the iabp was removed on (b)(6) 2020. It was reported the patient was fine as of (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004742232-2020-00070 |
| MDR Report Key | 9823475 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-10-10 |
| Date Added to Maude | 2020-03-12 |
| 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 | DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM |
| Generic Name | CORONARY ATHERECTOMY DEVICE |
| Product Code | MCX |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2020-02-25 |
| Model Number | DBEC-125 |
| Catalog Number | 70058-13 |
| Lot Number | 292925 |
| 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 | 2020-03-12 |