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

Model Number	DBP-200SOLID145
Medical Device Problem Codes	Entrapment of Device (1212); Device Contaminated at the User Facility (4064)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician took imaging of the left superficial femoral artery (sfa) prior treatment.The vessel was wired and ballooned.The diamondback 360 peripheral orbital atherectomy device (oad) was used to treat a 80-90% diffuse, diseased sfa.Two or three treatments of 20 seconds were performed with flushing in between.The oad was attempted to be removed, but there was resistance.The oad was stuck in tissue right above the sheath.The physician believed the access sheath was kinked.All products were removed ex-vivo and pressure was applied.Popliteal pulse was palpable, as well as distal pulses.The patient was in stable condition.Upon removal of the oad, there was tissue wrapped around the crown and catheter.
Additional Manufacturer Narrative
H6 investigation conclusion code 22: the diamondback 360® peripheral orbital atherectomy system instructions for use manual states that vessel injury is a potential adverse event that may occur and/or require intervention with use of the system.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 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.Csi id:(b)(4).

• Brand Name: DIAMONDBACK PERIPHERAL
• 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: aaron stevens ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 20310100
• Report Number: 3004742232-2024-00344
• Device Sequence Number: 8838209
• Product Code: MCW
• UDI-Device Identifier: 10850000491202
• UDI-Public: (01)10850000491202(17)251231(10)518715-1
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/26/2024

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: 12/31/2025
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: 7-10057-04
• Device Lot Number: 518715-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• 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: Other
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Race: White