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

Model Number	DBP-150SOLID200
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	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.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.The diamondback peripheral orbital atherectomy system instructions for use warns that a vessel perforation is a potential adverse event that may occur, and/or require intervention.Csi id: (b)(4).
Event or Problem Description
During a procedure, the viperwire guide wire was inadvertently advanced into the collateral artery and the diamondback peripheral orbital atherectomy device (oad) shut down after becoming stuck in the vessel.After one hour of troubleshooting, a balloon was used to free the oad from the vessel and a small perforation was identified.A prolonged balloon inflation was used to resolve the perforation and the patient was stable following the procedure.Per the opinion of the physician, the cause of the perforation event was due to inadvertently operating in the collateral artery.

• 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: 11668928
• Report Number: 3004742232-2021-00131
• Device Sequence Number: 16890862
• Product Code: MCW
• UDI-Device Identifier: 10850000491226
• UDI-Public: (01)10850000491226(17)220930(10)345176
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/14/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: DBP-150SOLID200
• Device Catalogue Number: 7-10057-06
• Device Lot Number: 345176
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/14/2021
• 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: 84 YR
• Patient Weight: 90