MAUDE Adverse Event Report: Cardiovascular Systems Incorporated Diamondback Coronary; Catheter, Coronary, Atherectomy

Model Number	GWC-12325LG-FT
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2026
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 the procedure was to treat heavily calcified, non-tortuous, 85% stenosed lesion in proximal to mid circumflex artery (cfx).The cfx was primarily wired with a viperwire advance coronary guide wire with flex tip which was positioned generously distal to the lesion.There was no wire bias.There was no difficulty wiring or delivering devices.Setup of the diamondback 360 coronary orbital atherectomy device (oad) was completed and 4 antegrade, proximal-to-distal treatments were successfully performed.A non-abbott guide wire was advanced and the viperwire was removed.As a puff of contrast was made the tip of the viperwire came into sight.With the injection the tip came from the guide wire and landed halfway out of the tip of guide wire and half into the ostium of the left anterior descending artery (lad).Examination of the fractured viperwire confirmed it was the spring tip.A snare was used to successfully extract the tip which remained in the snare device.Successful stent placement was used to complete the procedure.It was noted that the oad tip bushing never came anywhere close to the radiopaque tip of the viperwire.There were no adverse patient effects.The physician has no concerns about potential long-term risk outcomes.No additional information was provided.

• Brand Name: Diamondback Coronary
• Common Device Name: Catheter, Coronary, Atherectomy
• Manufacturer (Section D): Cardiovascular Systems Incorporated; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): Cardiovascular Systems Incorporated; 14740 kirby dr; houston TX 77047
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; +1(651)756-2718
• MDR Report Key: 25874260
• Report Number: 3004742232-2026-00182
• Device Sequence Number: 8037206
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• 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): 08/26/2026

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 Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 592374-1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/08/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2025
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 163 LB
• Patient Race: White