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

Model Number	DBP-150SOLID145
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported oad was received at csi for device analysis, along with the viperwire guide wire.Visual examination revealed adhered biological material on the driveshaft crown and on the guide wire.Analysis did not identify any damage that may have contributed to the accumulating material.When tested, the oad functioned as intended on all three speeds.The device data log revealed a stall event.At the conclusion of the device analysis investigation, the perforation and stuck in vessel events could not be confirmed, however the tissue on the driveshaft or crown area was confirmed.The accumulated biological material may have contributed to the reported events, however this could not be confirmed and the morphology and exact root cause of the accumulation was unknown.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).
Event or Problem Description
Orbital atherectomy treatment was selected for superficial femoral (sfa), posterior tibial (pt) and popliteal arteries.The lesion was a short chronic total occlusion and the vessel was primary wired with a non-csi wire.The diamondback peripheral orbital atherectomy device was operated in the sfa on all three speeds and in the pt on low speed without issue.When operated on medium speed in the pt the oad sounded as though it had spun in tissue, stopped spinning, and was stuck in the vessel.The oad was manually pulled to lremoval and tissue was observed around the tip of the device.Imaging did not reveal any issues, and balloon angioplasty was performed.Imaging identified a vessel perforation.Balloon angioplasty was unsuccessfully attempted for over 30 minutes, and a stent was placed to resolve the perforation.The procedure was continued without further complications, and the patient was in good condition following the procedure.Per the opinion of the physician, the non-csi primary wire was likely advanced to a subintimal location, and the oad was then operated subintimally.

• 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: 11645593
• Report Number: 3004742232-2021-00124
• Device Sequence Number: 19595523
• Product Code: MCW
• UDI-Device Identifier: 10850000491196
• UDI-Public: (01)10850000491196(17)220930(10)345508
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2021

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: 09/30/2022
• Device Model Number: DBP-150SOLID145
• Device Catalogue Number: 7-10057-03
• Device Lot Number: 345508
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/09/2021
• 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: 86 YR