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

Model Number	DBP-EX-125MIC145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that target vessel was heavily calcified superficial femoral artery (sfa) to popliteal to tibial peroneal trunk(tpt) to posterior tibial (pt) to pedal loop.The lesion was greater than 70% throughout each artery, approximately 450 cm in total disease length treated.The physician was able to easily navigate an 0.014 through the calcified disease and around the pedal loop with an 0.014 non-abbott guidewire.It was then swapped for an 0.014 viperwire peripheral guidewire.Atherectomy was performed up to medium speed using a a diamondback 360 peripheral exchange orbital atherectomy device (oad) in popliteal-tpt-pt.Then the cartridge on the exchangeable device was swapped for a micro crown which was used to perform atherectomy in the pedal loop.It was noted flushing was performed between each run and 30 seconds of treatment to rest was also followed.Act was drawn and within normal range for intervention.Embolization of the distal vessels in the patient¿s foot occurred as a result of orbital atherectomy system.Angioplasty was performed using balloons of varying sizes and it was noted that flow had been lost in the pt and down the pedal loop.It was a case of persistent no-flow.There was loss of outflow and intra-arterial nitroglycerine was injected into the foot through support catheters and 2.0 - 2.5 mm balloons were used to inflate into the pedal loop.The patient was recovering well without lasting complications from loss of outflow.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

• 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: 50459610
• Report Number: 3004742232-2026-00205
• Device Sequence Number: 9811205
• Product Code: MCW
• UDI-Device Identifier: 10852528005817
• UDI-Public: (01)10852528005817(17)280430(10)608487
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 10/02/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: DBP-EX-125MIC145
• Device Catalogue Number: 7-10030-01
• Device Lot Number: 608487
• 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: 08/03/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2026
• 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