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

Model Number	DBP-EX-125MIC145
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported oad was received at csi for analysis.Visual examination did not initially reveal any issues, however when tested fluid was observed leaking from the nose cone to the saline sheath bond site.The assembly was reviewed and it was determined that there was insufficient adhesive within the saline sheath to nose cone bond site.During functional tested, the oad operated as expected.At the conclusion of the device analysis investigation, the report that the saline sheath had separated and fluid was leaking from the device was confirmed.The root cause was determined to be a manufacturing issue due to the lack of sufficient adhesive.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
During orbital atherectomy treatment to the proximal anterior tibial artery, fluid was observed to be leaking from the diamondback exchangeable orbital atherectomy device (oad), and the saline sheath was detached.The vessel was not being perfused, and per the physician the flow of saline to the tip of the oad was not sufficient enough to prevent patient injury.The device was replaced with a second oad to complete the procedure, without any patient complications.

• 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: 11496289
• Report Number: 3004742232-2021-00078
• Device Sequence Number: 17143110
• Product Code: MCW
• UDI-Device Identifier: 10852528005817
• UDI-Public: (01)10852528005817(17)220930(10)343991
• 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): 03/16/2021

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: 09/30/2022
• Device Model Number: DBP-EX-125MIC145
• Device Catalogue Number: 7-10030-01
• Device Lot Number: 343991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 156