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

Model Number	DBP-150SOLID145
Medical Device Problem Codes	Entrapment of Device (1212); Unintended System Motion (1430); Difficult to Remove (1528); Device Contaminated at the User Facility (4064)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
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
It was reported that during procedure to treat 100% stenosed, heavily calcified superficial femoral artery (sfa).A viperwire peripheral guidewire was passed through a long chronic total occluded (cto) segment of sfa from pedal access and brought through femoral destination sheath.There was no evidence of subintimal wire placement that was noted.Intravascular ultrasound (ivus) was not performed.The crown of diamondback 360 coronary orbital atherectomy device (oad) was advanced to proximal sfa and the oad was spun slowly on low-speed working through the cto of sfa.The oad crown made no noise indicating the crown was spinning through a dissection plane.It jumped forward one time and treatment was stopped.The oad crown was retracted.It was planned to treat a bit more section of the sfa.The crown seemed to be stuck upon removal.A 0.14 wire was inserted and a balloon was placed around the crown.Nitroglycerin was administered through the oad in an attempt to relieve the crown form being stuck.Nothing was successful and therefore, a 0.35 wire was placed down the destination sheath.The destination sheath and crown were removed.Tissue was noted to be wrapped around the crown.The vessel was able to be ballooned.A stent was placed to restore flow to the sfa.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Updated fields: b5, d9, g3, g6, h2.Correction: h6 (health effect - clinical code and medical device problem code added).
Event or Problem Description
It was reported that during procedure to treat 100% stenosed, heavily calcified superficial femoral artery (sfa), a viperwire peripheral guidewire was passed through a long chronic total occluded (cto) segment of sfa from pedal access and brought through femoral destination sheath.There was no evidence of subintimal wire placement that was noted.Intravascular ultrasound (ivus) was not performed.The crown of diamondback 360 peripheral orbital atherectomy device (oad) was advanced to proximal sfa and the oad was spun slowly on low speed working through the cto of sfa.The oad crown made no noise indicating the crown was spinning through a dissection plane.It jumped forward one time and treatment was stopped.The oad crown was retracted.It was planned to treat a bit more section of the sfa.The crown seemed to be stuck upon removal.A 0.14 wire was inserted and a balloon was placed around the crown.Nitro was administered through the oad in an attempt to relieve the crown form being stuck.Nothing was successful and therefore, a 0.35 wire was placed down the non-abbott sheath.The non-abbott sheath and crown were removed.Tissue was noted to be wrapped around the crown.A new non-abbott sheath was placed and the vessel was able to be ballooned.A stent was placed to restore flow to the sfa.Additional information was received and the device as it seemed to enter a dissection plane that was not evident angiographically.The vessel was sized with a 5.0 balloon.The treatment was performed proximal to distal.Slight amount of pain noted while removing the oad.The patient was stable with good flow to the leg.
Event or Problem Description
It was reported that during procedure to treat 100% stenosed, heavily calcified superficial femoral artery (sfa), a viperwire peripheral guidewire was passed through a long chronic total occluded (cto) segment of sfa from pedal access and brought through femoral destination sheath.There was no evidence of subintimal wire placement that was noted.Intravascular ultrasound (ivus) was not performed.The crown of diamondback 360 peripheral orbital atherectomy device (oad) was advanced to proximal sfa and the oad was spun slowly on low speed working through the cto of sfa.The oad crown made no noise indicating the crown was spinning through a dissection plane.It jumped forward one time and treatment was stopped.The oad crown was retracted.It was planned to treat a bit more section of the sfa.The crown seemed to be stuck upon removal.A 0.14 wire was inserted and a balloon was placed around the crown.Nitro was administered through the oad in an attempt to relieve the crown form being stuck.Nothing was successful and therefore, a 0.35 wire was placed down the non-abbott sheath.The non-abbott sheath and crown were removed.Tissue was noted to be wrapped around the crown.A new non-abbott sheath was placed and the vessel was able to be ballooned.A stent was placed to restore flow to the sfa.Additional information was received and the device as it seemed to enter a dissection plane that was not evident angiographically.The vessel was sized with a 5.0 balloon.The treatment was performed proximal to distal.Slight amount of pain noted while removing the oad.The patient was stable with good flow to the leg.
Additional Manufacturer Narrative
A visual inspection, functional testing, dimensional analysis, and detailed analysis were performed on the returned device.The reported crown being stuck upon removal, and tissue wrap around the crown were confirmed through analysis.The reported crown jumping was not confirmed through 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 reported information and the observations from the returned analysis, the investigation determined that the report of the crown jumping, the crown being stuck upon removal, and tissue wrap around the crown appear to be related to circumstances of the procedure.The returned crown was wrapped in tissue, and the driveshaft was elongated which is consistent with a driveshaft that is stuck and is pulled in tension during attempted removal.The complaint reported that the device seemed to enter a dissection plane that was not evident angiographically.Spinning the crown in the presence of a dissection may result in increased vessel interaction.There was no damage or abnormalities observed on the crown or device that would have contributed to the reported complaint.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.Updated fields: g3, g6, h2, h3, h6 (component code, type of investigation, investigation findings, investigation conclusions).

• 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, #3008814558; 14740 kirby dr; houston TX 77047
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 24709281
• Report Number: 3004742232-2026-00067
• Device Sequence Number: 10439976
• Product Code: MCW
• UDI-Device Identifier: 10850000491196
• UDI-Public: (01)10850000491196(17)271031(10)588657-1
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/18/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: DBP-150SOLID145
• Device Catalogue Number: 7-10057-03
• Device Lot Number: 588657-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 04/02/2026; 05/04/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/30/2026; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2025
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White