MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number	DBP-200SOLID145
Medical Device Problem Codes	Mechanical Problem (1384); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad was received at csi for analysis, with the viperwire guide wire engaged, and a introducer sheath over the driveshaft and saline sheath areas.Visual examination confirmed the crown was detached from the driveshaft.There was no damage observed with the crown.The driveshaft filars were stretched and elongated at the crown weld location, extending proximally along the driveshaft.There was no damage observed with the guide wire.Scanning electronic microscopy analysis confirmed there was a sufficient amount of solder to provide an adequate crown weld.When tested, the oad spun on all speeds, and functioned as intended.At the conclusion of the device analysis, the reported event was partially confirmed.The crown was confirmed to have been detached from the driveshaft, and it was hypothesized that the root cause was due to user error.The reported event that the oad had stopped spinning could not be confirmed.The diamondback coronary orbital atherectomy system instructions for use states, "do not continue treatment if the wire or the device becomes sub-intimal." 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.Patient weight is approximate.(b)(4).
Event or Problem Description
A diamondback peripheral orbital atherectomy device (oad) was selected for treatment of a chronic total occlusion (cto), located in the left superficial femoral artery (sfa).The oad was intentionally operated in a subintimal section of the vessel, on low speed for ten seconds.The device stopped spinning, and the crown of the oad could not be moved backwards through the introducer sheath.Both the introducer sheath and oad were forcefully removed from the cto.During attempts to move the crown backward the oad was pulled, and the crown fractured off.An additional access site was opened, and the fragment was retrieved with the use of a snare device.The procedure was continued with successful stent placement in the iliac vessel.The patient was doing well and additional treatment to the cto is anticipated.The physician believed he would be able to operate successfully in the subintimal region of the sfa.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 9948228
• Report Number: 3004742232-2020-00115
• Device Sequence Number: 17003028
• Product Code: MCW
• UDI-Device Identifier: 10852528005275
• UDI-Public: (01)10852528005275(17)211130(10)297016
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: DBP¿200SOLID145
• Device Lot Number: 297016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 73