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

Model Number	DBP-EX-125SOL145
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a command guide wire was attempted to be exchanged for a viperwire advance guide wire, however, due to the heavily calcified anatomy it was unsuccessful.The physician elected to continue to use the command guide wire with the diamondback 360 exchangeable peripheral orbital atherectomy device (oad).A low speed and medium speed treatment were performed.The oad made contact with the wire radiopaque tip.The oad was removed and the wire remained in vivo for additional treatments.Once the wire was removed, it was observed to have fractured.The fractured wire remains in vivo.The patient was stable.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional device referenced in b5 is filed under separate medwatch report number.
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.It was reported it was reported that a command guide wire was attempted to be exchanged for a viperwire advance guide wire, however, due to the heavily calcified anatomy it was unsuccessful.The physician elected to continue to use the command guide wire with the diamondback 360 exchangeable peripheral orbital atherectomy device (oad).A low speed and medium speed treatment were performed.The oad made contact with the wire radiopaque tip.The oad was removed and the wire remained in vivo for additional treatments.Once the wire was removed, it was observed to have fractured.The dback periph exch 1.25mm sl 145cm oad us instruction for use (ifu), warns: ¿the device is designed to track and spin only over the csi peripheral viperwire advance guide wire or the viperwire advance with flex tip guide wire.Do not use any other guide wire with this device.¿ in this case, it is likely that the violation of the ifu contributed to the reported damage.Based on the information received, the investigation determined that the reported device causing damage to another device appears to be related to user error.In this case it is likely that the reported damage is due to using the exchangeable orbital atherectomy device with a non-viperwire guide wire; 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
It was reported that a command guide wire was attempted to be exchanged for a viperwire advance guide wire, however, due to the heavily calcified anatomy it was unsuccessful.The physician elected to continue to use the command guide wire with the diamondback 360 exchangeable peripheral orbital atherectomy device (oad).A low speed and medium speed treatment were performed.The oad made contact with the wire radiopaque tip.The oad was removed and the wire remained in vivo for additional treatments.Once the wire was removed, it was observed to have fractured.The fractured wire remains in vivo.The patient was stable.

• 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: 21172265
• Report Number: 3004742232-2025-00017
• Device Sequence Number: 11831296
• Product Code: MCW
• UDI-Device Identifier: 10852528005824
• UDI-Public: (01)10852528005824(17)260531(10)538702
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 03/04/2025

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: 05/31/2026
• Device Model Number: DBP-EX-125SOL145
• Device Catalogue Number: DBP-EX-125SOL145
• Device Lot Number: 538702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• 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: Unknown