MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK PERIPHERAL; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	DBP-125MICRO145
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	05/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
A 1.25 micro crown diamondback 360 peripheral orbital atherectomy device (oad) was used on low-speed for successful treatment of a calcified, non-tortuous lesion in right tibial arteries through left common femoral artery (cfa) access.The right pedal loop was going to be treated next but the oad became stuck in the right pedal loop.The oad was put on glideassist and was turned on and off, however, the device continued to be stuck in the vessel.Surgery was performed to remove the oad without further complications.The patient was discharged the same day.
Event or Problem Description
A 1.25 micro crown diamondback 360 peripheral orbital atherectomy device (oad) was used on low-speed for successful treatment of a calcified, non-tortuous lesion in right tibial arteries through left common femoral artery (cfa) access.The right pedal loop was going to be treated next but the oad became stuck in the right pedal loop.The oad was put on glideassist and was turned on and off, however, the device continued to be stuck in the vessel.Surgery was performed to remove the oad without further complications.The patient was discharged the same day.
Additional Manufacturer Narrative
Additional information: h6.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 entrapment of device, device contaminated at the user facility, device embedded in tissue and surgical intervention, appears to be related to operational context.In this case, it is possible that the reported entrapment of device, device contaminated at the user facility, device embedded in tissue and surgical intervention are related to device placement 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.
Additional Manufacturer Narrative
Additional information: a1, b5, h10, e4.Correction: b1.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 entrapment of device, device contaminated at the user facility, device embedded in tissue and surgical intervention, appears to be related to operational context.In this case, it is possible that the reported entrapment of device, device contaminated at the user facility, device embedded in tissue and surgical intervention are related to device placement 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.
Event or Problem Description
A 1.25 micro crown diamondback 360 peripheral orbital atherectomy device (oad) was used on low-speed for successful treatment of a calcified, non-tortuous lesion in right tibial arteries through left common femoral artery (cfa) access.The right pedal loop was going to be treated next but the oad became stuck in the right pedal loop.The oad was put on glideassist and was turned on and off, however, the device continued to be stuck in the vessel.Surgery was performed to remove the oad without further complications.The patient was discharged the same day.Additional information received indicated that there was tissue noted on the driveshaft following the surgical cutdown to remove 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 ; 6517562718
• MDR Report Key: 22141135
• Report Number: 3004742232-2025-00161
• Device Sequence Number: 7276429
• Product Code: MCW
• UDI-Device Identifier: 10850000491172
• UDI-Public: (01)10850000491172(17)260731(10)545897-1
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K220568
• 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,Followup,Followup
• Report Date (Section B): 09/19/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: 7-10057-01
• Device Lot Number: 545897-1
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 06/26/2025; 09/11/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/26/2025; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2024
• 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: 62 YR
• Patient Sex: Male