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

Model Number	DBP-EX-125SOL145
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A treatment was performed in the 3 mm, heavily calcified lesion in the proximal anterior tibial (at) diamondback 360 exchangeable orbital atherectomy device (oad) on low speed.The device was flushed, and a second treatment was performed on low speed when the crown became stuck.Glideassist was activated, but multiple attempts to remove the crown were unsuccessful.Two treatments of intra-arterial nitroglycerin were administered via the oad.The oad was flushed with viperslide, and glideassist was activated, but the crown remained stuck.By holding the wire, the oad was able to be removed successfully.Angiographic imaging revealed good flow and no dissection.Balloon angioplasty was used.A new oad and wire were used to treat two additional lesions which restored complete flow to the pedal arch.
Additional Manufacturer Narrative
Investigation findings code: (b)(4): suggested code is biological material present on device.The device was returned to csi for analysis.At receipt, the device was returned with the guide wire.Analysis revealed biological material was adhered on the driveshaft crown.The accumulation caused resistance when passing a test wire through during analysis.Examination did not reveal any damage that would have contributed to the accumulation.The biological accumulation may have contributed to the device becoming stuck in the vessel, however, cannot be confirmed.The crown diameter was measured and met specifications.Further testing displayed that the device functioned as intended.The root cause of the accumulation cannot 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.Csi id: (b)(6).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 15067636
• Report Number: 3004742232-2022-00171
• Device Sequence Number: 5722881
• Product Code: MCW
• UDI-Device Identifier: 10852528005824
• UDI-Public: (01)10852528005824(17)231130(10)410213
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2022

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: 11/30/2023
• Device Model Number: DBP-EX-125SOL145
• Device Catalogue Number: 7-10030-02
• Device Lot Number: 410213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White