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 2020-03-16 for DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM GWC-12325LG-FT 7-10038-01 manufactured by Cardiovascular Systems, Inc..
[183535943]
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
[183535944]
The coronary orbital atherectomy device (oad) was operated for two treatment passes in a 99% stenosed, extremely tortuous lesion in the proximal circumflex. The oad was observed to jump forward during treatment. The coronary viperwire guide wire pulled back at the same time, resulting in the tip of the wire becoming detached. No attempts were made to retrieve the wire fragment. A surgical consult was obtained and it was determined that leaving the fragment in vivo would not be detrimental to the patient. The patient remained stable throughout the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004742232-2020-00079 |
| MDR Report Key | 9835636 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2019-11-25 |
| Date Added to Maude | 2020-03-16 |
| 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 | MRS. LARAMIE OTTO |
| Manufacturer Street | 1225 OLD HIGHWAY 8 NW |
| Manufacturer City | ST. PAUL, MN, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 2591600 |
| Manufacturer G1 | CARDIOVASCULAR SYSTEMS, INC. |
| Manufacturer Street | 1225 OLD HIGHWAY 8 NW |
| Manufacturer City | ST. PAUL, MN, 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 | 2020-03-16 |
| Returned To Mfg | 2020-02-27 |
| Model Number | GWC-12325LG-FT |
| Catalog Number | 7-10038-01 |
| Lot Number | 299047 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 ST. PAUL, MN, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-16 |