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

Model Number	DBE-150
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.This event is considered reportable due to behavior of the device noticed during ex vivo troubleshooting following a non-reportable complaint.Csi id: (b)(6).
Event or Problem Description
Orbital atherectomy treatment with a stealth orbital atherectomy device (oad) was selected for a long diffusely diseased right superficial femoral, popliteal tibial and tibioperoneal trunk arteries.Several treatments were administered on each speed in the first two lesions.The oad was advanced to the third lesion, however the oad did not spin when prompted.Despite troubleshooting, the issue recurred.The oad was removed and replaced with a second device to continue treatment.The procedure was completed with balloon angioplasty.Additional ex vivo testing was performed, and the oad spun.However, it would not stop spinning until the brake was unlocked.
Additional Manufacturer Narrative
The reported oad was received at csi for analysis.Visual examination did not reveal any damage.When tested for functionality, the oad was powered on and off numerous times, with no issues observed with the start switch.When reviewed, the device data log revealed troubleshooting attempts.At the conclusion of the device investigation analysis, the report that the oad stopped spinning and when tested outside of the body would not stop spinning could not be confirmed through analysis.There was no damage observed on the oad and no events reviewed on the device data log that would have contributed to the stopped spinning and would not stop spinning events.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.Csi id: (b)(4).

• 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 55112
• MDR Report Key: 10741838
• Report Number: 3004742232-2020-00338
• Device Sequence Number: 3486266
• Product Code: MCW
• UDI-Device Identifier: 10850000491332
• UDI-Public: (01)10850000491332(17)220331(10)319814
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: DBE-150
• Device Catalogue Number: 7-10059-08
• Device Lot Number: 319814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 77