MAUDE Adverse Event Report: Cardiovascular Systems Incorporated Diamondback Peripheral; Catheter, Peripheral, Atherectomy

Model Number	DBP-EX-200SOL145
Medical Device Problem Codes	Noise, Audible (3273); Device Contaminated at the User Facility (4064)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Embolism/Embolus (4438)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a diamondback 2.0 solid peripheral orbital atherectomy device (oad) was used in moderately calcified and mildly tortuous left superficial femoral artery (sfa) chronic total occlusion (cto) and during treatment the physician noticed an audible difference and stopped the use of oad.Two treatments were performed with the oad before the reported issue was observed.There were no observed device issues noticed before the audible sound.The noise heard was low pitch.During removal, it was noticed intima was wrapped around the crown under live x-ray.The cause of embolism was while removing it through the sheath, the tissue/intima came off the crown and went downstream.After oad removal, the physician used a non-abbott device to perform thrombectomy to remove a piece of intima that had traveled downstream in the posterior tibial.Patient had no other complications or symptoms after removal.The patient was stable.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the information received, the investigation determined that the reported unusual noise, device contaminated at the user facility, device embedded in tissue or plaque, embolism and unexpected medical intervention appears to be related to operational context.In this case it is possible that the reported unusual noise, device contaminated at the user facility, device embedded in tissue or plaque, embolism and unexpected medical intervention are a result of the patient¿s disease severity and/or use techniques employed; however, since the device was not returned this could not be confirmed.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: Diamondback Peripheral
• Common Device Name: Catheter, Peripheral, Atherectomy
• Manufacturer (Section D): Cardiovascular Systems Incorporated; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): Cardiovascular Systems Incorporated, #3004742232; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; +1(651)756-2718
• MDR Report Key: 50734561
• Report Number: 3004742232-2026-00218
• Device Sequence Number: 10599348
• Product Code: MCW
• UDI-Device Identifier: 10852528005848
• UDI-Public: (01)10852528005848(17)280228(10)602630
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K203008
• 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): 09/11/2026

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 Model Number: DBP-EX-200SOL145
• Device Catalogue Number: 7-10030-04
• Device Lot Number: 602630
• 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: 08/19/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2026
• 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 Sex: Unknown