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

Model Number	DBP-EX-125MIC145
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Variance permits numbering sequence to deviate from the definition of a manufacturer report number found in 21 cfr part 803.3 (m)(3), to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 a diamondback 360 exchangeable peripheral orbital atherectomy device (oad) was used for treatment of the distal anterior tibial artery via femoral access.The lesion was 2.0 mm in diameter, 95% stenosed, heavily calcified and mildly tortuous.Upon advancing the oad on low speed for the first time to the distal lesion by the ankle, the oad became stuck and shut down, consistent with safety mechanism.The oad could not be retracted.Manipulation of the crown was attempted using glideassist to retract the oad over the viperwire with no success.An incision was made at the foot to successfully free the crown.The oad was removed.The patient was stable.The physician believes the oad became stuck due to patient anatomy and disease.On (b)(6) 2024, the abbott senior reliability technician indicated that the oad driveshaft was received fractured at the crown area and the distal fractured section was returned.
Additional Manufacturer Narrative
H6: codes 4755, 4118, 3233, and 11 no longer are applicable.A visual inspection, functional testing, dimensional analysis and data log analysis were performed on the returned device.The reported entrapment of device, device embedded in tissue or plaque, and surgical intervention were not able to be confirmed due to the operational context of the reported issue.The material separation is due to the shaft being deliberately cut and is not considered a contributing factor in the reported compliant.Engineering review of the device data log identified stall events.It is likely that the stall events are related to the reported complaints.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 entrapment of device, device embedded in tissue or plaque, surgical intervention and material separation appears to be related to circumstances of the procedure.There was no damage or abnormalities identified with the device that would have contributed to the reported complaint.Per complaint details, ¿the physician believes the device became stuck due to patient anatomy and disease¿ (95% stenosis and heavily calcified).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 a diamondback 360 exchangeable peripheral orbital atherectomy device (oad) was used for treatment of the distal anterior tibial artery via femoral access.The lesion was 2.0 mm in diameter, 95% stenosed, heavily calcified and mildly tortuous.Upon advancing the oad on low speed for the first time to the distal lesion by the ankle, the oad became stuck and shut down, consistent with safety mechanism.The oad could not be retracted.Manipulation of the crown was attempted using glideassist to retract the oad over the viperwire with no success.An incision was made at the foot to successfully free the crown.The oad was removed.The patient was stable.The physician believes the oad became stuck due to patient anatomy and disease.On 27november2024, the abbott senior reliability technician indicated that the oad driveshaft was received fractured at the crown area and the distal fractured section was returned.

• 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: 20924237
• Report Number: 3004742232-2024-01024
• Device Sequence Number: 14732175
• Product Code: MCW
• UDI-Device Identifier: 10852528005817
• UDI-Public: (01)10852528005817(17)260531(10)539712
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220568
• Exemption Number: GEN2400518
• 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): 02/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: DBP-EX-125MIC145
• Device Catalogue Number: DBP-EX-125MIC145
• Device Lot Number: 539712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 84 KG