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

Model Number	DBP-EX-125SOL145
Medical Device Problem Codes	Entrapment of Device (1212); Activation Problem (4042)
Health Effect - Clinical Codes	Vasoconstriction (2126); Foreign Body In Patient (2687)
Date of Event	02/24/2025
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 left femoral access was used with a 6f non-abbott sheath and a wire exchange was performed for the viperwire guide wire.The diamondback 360 peripheral exchangeable orbital atherectomy device (oad) was used for two low speed treatments and one medium speed treatment of a heavily calcified right anterior tibial artery (at).The physician attempted to advance the oad further down the at, however, they were unable to advance further.The physician put the oad in glideassist mode.During advancement, glideassist slowed down and the loss in speed was observed audibly.It appeared that the oad was stuck in vessel that resulted on loss of speed.It was recommended for the oad to be removed.The oad was put in glideassist mode in an attempt to remove the device.The same issue occurred during removal.Glideassist mode slowed and stopped.The oad was unable to be removed and it was indicated the at spasmed.Verapamil and a full radial cocktail were administered.The spasm did not resolve.The physician ended up cutting the tip of the oad, hoping to relieve pressure, but the issue remained unresolved.A guide catheter and a new viperwire were inserted in an attempt to loosen the oad crown, but this was unsuccessful.After hours of attempting to remove the oad, the patient was sent for surgery the next day.The surgery was completed successfully the patient was discharged home.The oad was completely removed from the patient's body.
Event or Problem Description
It was reported left femoral access was used with a 6f cook sheath and a wire exchange was performed for the viperwire guide wire.The diamondback 360 peripheral exchangeable orbital atherectomy device (oad) was used for two low speed treatments and one medium speed treatment of a heavily calcified right anterior tibial artery (at).The physician attempted to advance the oad further down the at, however, they were unable to advance further.The physician put the oad in glideassist mode.During advancement, glideassist slowed down and the loss in speed was observed audibly.It appeared that the oad was stuck in vessel that resulted on loss of speed.It was recommended for the oad to be removed.The oad was put in glideassist mode in an attempt to remove the device.The same issue occurred during removal.Glideassist mode slowed and stopped.The oad was unable to be removed and it was indicated the at spasmed.Verapamil and a full radial cocktail were administered.The spasm did not resolve.The physician ended up cutting the tip of the oad, hoping to relieve pressure, but the issue remained unresolved.A guide catheter and a new viperwire were inserted in an attempt to loosen the oad crown, but this was unsuccessful.After hours of attempting to remove the oad, the patient was sent for surgery the next day.The surgery was completed successfully the patient was discharged home.The oad was completely removed from the patient's body.
Additional Manufacturer Narrative
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.Based on the information received, the investigation determined that the reported enrapment of device, and related activation problem, vasoconstricton, foreign body in patient, medication and surgical intervention appears to be related to operational context.In this case it is likely that the reported enrapment of device, and related activation problem, vasoconstricton, foreign body in patient, medication and surgical intervention are a result of the patient¿s disease severity combined with use techniques employed; 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.Updated fields: g3, g6, h2, h6 (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, #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: 21656842
• Report Number: 3004742232-2025-00057
• Device Sequence Number: 12637268
• Product Code: MCW
• UDI-Device Identifier: 10852528005824
• UDI-Public: (01)10852528005824(17)250630(10)497391
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/29/2025

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: 06/30/2025
• Device Model Number: DBP-EX-125SOL145
• Device Catalogue Number: 7-10030-02
• Device Lot Number: 497391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2023
• 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: 66 YR
• Patient Sex: Female