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

Model Number	DBP-200SOLID145
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Shaft filars at the proximal edge of the crown.Scanning electron microscopy analysis of the filar fractures showed evidence of torsion and fatigue.It was reported to csi that the crown had spun backwards into the sheath and damaged the sheath and driveshaft.It is hypothesized that the fracture may have been due to this interaction.However, the exact cause of the fractures remains unknown.During testing, the oad did not exhibit any unexpected proximal movement.Stall events were recorded in the device data log, which also confirms that the device stopped spinning during the procedure.The cause of the stall events was likely related to the events leading up to the filar fractures; however, this could not be conclusively confirmed.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.
Event or Problem Description
Several treatments were administered with a diamondback peripheral orbital atherectomy device (oad).The device then stopped spinning.The crown had spun backwards into the sheath, thereby causing damage to the sheath and oad driveshaft.Difficulty was encountered in removing the oad from the guide wire and in pulling the oad back into the sheath.A wire was inserted to maintain wire position, and the oad, guide wire, and sheath were removed.Upon further observation, the oad driveshaft had unraveled near the crown.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 12562073
• Report Number: 3004742232-2021-00334
• Device Sequence Number: 11096948
• Product Code: MCX
• UDI-Device Identifier: 10850000491202
• UDI-Public: (01)10850000491202(17)220930(10)345224
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• 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): 10/01/2021

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-200SOLID145
• Device Catalogue Number: 7-10057-04
• Device Lot Number: 345224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 100