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

Model Number	DBP-EX-125SOL145
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad was received at csi for analysis engaged on the guide wire.Visual examination revealed adhered biological material on the driveshaft crown section.The guide wire was removed from the driveshaft without resistance.Examination of the guide wire did not reveal any damage.The wire passed through the area of biological material without issue.When tested, the oad functioned as intended.At the conclusion of the device analysis investigation, the report that the oad was stuck in the vessel and stuck on the guide wire were not confirmed through analysis; however, the report that tissue was observed on the driveshaft or crown was confirmed.Examination of the adhered material did not reveal any damage that would have contributed to the accumulation 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.(b)(4).
Event or Problem Description
A diamondback exchangeable orbital atherectomy device (oad) was used via pedal access and antegrade approach to treat a chronic total occlusion in the left anterior tibial artery.Atherectomy was performed on low speed proximal-to-distal throughout the lesion.The oad was unable to spin back to the proximal starting point.A catheter was inserted and advanced to the oad nose, which freed the device; however, the device was stuck on the guide wire and due to the tissue wrapped around the driveshaft, the device was unable to be removed through the sheath.A buddy wire was advanced to the left superficial femoral artery and the oad, viperwire guide wire and sheath were then removed together.Tissue wrap was observed on both the guide wire and oad.The catheter that was used to free the oad was used to maintain wire access, the vessel was rewired, and the procedure was completed with balloon angioplasty.The patient was doing well following the procedure.Additional review of imaging confirmed that the csi device was subintimal when the device became stuck in the vessel.

• 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
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 12855986
• Report Number: 3004742232-2021-00382
• Device Sequence Number: 4018734
• Product Code: MCW
• UDI-Device Identifier: 10852528005824
• UDI-Public: (01)10852528005824(17)230531(10)381292
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/22/2021

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: 05/31/2023
• Device Model Number: DBP-EX-125SOL145
• Device Catalogue Number: 7-10030-02
• Device Lot Number: 381292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• 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: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White