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

Model Number	DBP-125SOLID145
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection, functional testing and detailed analysis were performed on the returned device.The reported unexpected shutdown was confirmed.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 reported information and the observations from the returned analysis, the investigation determined that the reported unexpected shutdown appears to be related to circumstances of the procedure.The oad was returned with a driveshaft fracture at the distal edge of the crown.Sem analysis of the driveshaft fracture identified evidence of fatigue indicating that the fracture occurred while spinning in an elevated stress environment.The exact cause is unknown.The relationship between the stall event and the driveshaft fracture, if any, is unknown.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
It was reported that during peripheral intervention of the left leg via right femoral artery & left posterior tibial (pt) pedal access, a viperwire peripheral guidewire was advanced down into the distal peroneal artery.The 1.25 solid diamondback peripheral orbital atherectomy device (oad) was placed over the viperwire guidewire to treat the tibioperoneal (tp) trunk and down to about the mid-peroneal.At some point between checking the viperwire guidewire tip placement and then actually starting the treatment, the guidewire was pulled back and then advanced deep into a collateral.During first treatment, a slack in the viperwire guidewire was noticed on the flouroscopy monitor.The guidewire fractured and the oad automatically shut off.The oad was removed, two guidewire fragments left in-vivo.The majority of the tip of the viperwire guidewire spring tip was lodged deep into a collateral off of the peroneal.A small piece of wire fragment was at the distal to the takeoff of the peroneal.Multiple snares were used to try and remove the fragments but were unsuccessful.At this point it was noticed that the small proximal fragment piece was mostly occlusive and there was no flow in either the pt or peroneal.An esprit 3.5x38 was placed starting in the tp trunk and crossing the peroneal/pt bifurcation into the peroneal artery to trap the piece of wire against the wall which successfully in re-established flow into the peroneal.Left pedal pt access was then obtained to try and re-open the pt.A 014 command wire was placed up through the pt and passed through the scaffold struts into the popliteal artery.Additional dilatation was performed to post-dilate to a larger size than what had previously.A 2.0x40 jade balloon was used to balloon open the scaffold strut to get flow back into the pt.After that the peroneal and pt bifurcation was ballooned simultaneously using a "kissing balloon" technique.The complication added significant time to the procedure.The procedure was successfully completed with three vessel runoff.Device analysis identified a driveshaft fracture observed at the distal edge of the crown.

• 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: 23369859
• Report Number: 3004742232-2025-00318
• Device Sequence Number: 12985251
• Product Code: MCW
• UDI-Device Identifier: 10850000491189
• UDI-Public: (01)10850000491189(17)260430(10)534440-1
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 10/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: 7-10057-02
• Device Lot Number: 534440-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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
• Patient Sex: Male
• Patient Race: Black Or African American