MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-20 for DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM VPR-GW-14 72023-01 manufactured by Cardiovascular Systems, Inc..
[184299855]
The peripheral orbital atherectomy device (oad) was received at csi for analysis, engaged with the viperwire guide wire. There was no damage observed with the handle, driveshaft or crown area of the oad. Adhered biological material was observed on the driveshaft. The morphology and root cause of the biological material could not be determined. Analysis of the crown did not reveal any damage that would have contributed to the tissue accumulation. When tested, the oad functioned as intended with no issues observed. Visual examination of the guide wire spring tip confirmed it was engaged within the oad driveshaft and tip bushing. The spring tip was destructively removed from the driveshaft tip bushing and crown section. The proximal spring tip coil was damaged, and fractured at the proximal solder bond area. It could not be determined if the fracture was present prior to destructively removing the spring tip from the driveshaft or if the damage was the result of the spring tip coming into contact with the driveshaft. Scanning electron microscopy analysis revealed solder particles in the tip bushing. The proximal spring tip coils did not exhibit obvious rotational damage. The root cause of the device becoming stuck on the wire was hypothesized to be user error as the spring tip coils were pulled into the driveshaft tip bushing. At the conclusion of the device analysis investigation, the report that the oad stopped spinning was not confirmed, however the oad becoming stuck on the wire was confirmed. The diamondback 360 peripheral orbital atherectomy device instructions for use states, "the maximum travel of the crown advancer knob and therefore the shaft tip is 15 cm. Moving the crown advancer knob forward moves the shaft tip an equal distance toward the guide wire spring tip. When moving the crown advancer knob, make sure there is sufficient distance between the guide wire spring tip and the distal end of the shaft (10 cm minimum). If the distance between the shaft tip and the guide wire spring tip is insufficient, the shaft tip may damage the guide wire spring tip and result in dislodgement of the guide wire spring tip. Use contrast injections and fluoroscopy to monitor movement of the shaft tip in relation to the guide wire spring tip. " the material inspection report for this guide wire 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
[184299856]
A viperwire guide wire fracture was identified during analysis of the guide wire and a peripheral orbital atherectomy device (oad). It was initially reported that the oad became stuck on the guide wire and stopped spinning and that the oad may have come into contact with the spring tip of the viper wire guide wire. This fracture was not reported or observed by the customer, and the customer stated the device appeared intact during the procedure with no fragments observed as being present in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004742232-2020-00088 |
| MDR Report Key | 9859620 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-10-02 |
| Date Added to Maude | 2020-03-20 |
| 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 | BRITTANY LEIDER |
| Manufacturer Street | 1225 OLD HIGHWAY 8 NW |
| Manufacturer City | SAINT PAUL, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 2591600 |
| 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 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM |
| Generic Name | PERIPHERAL ATHERECTOMY DEVICE |
| Product Code | MCW |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-02-03 |
| Model Number | VPR-GW-14 |
| Catalog Number | 72023-01 |
| Lot Number | 291634 |
| 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 | 2020-03-20 |