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	Foreign Body In Patient (2687)
Date of Event	05/13/2026
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 proximal left anterior descending (lad) highly calcified, non-tortuous lesion, a non-abbott wire was inserted via the right femoral artery through an ebu 3.5 guide catheter.A 2.5 x 15 sapphire balloon was inserted over non-abbott wire and inflated proximal.A non-abbott catheter was inserted over the wire after the balloon was removed.The non-abbott wire was removed and viperwire coronary flex guidewire was inserted through the non-abbott catheter.Several treatments runs were performed successfully at 80,000 rpm.It appeared that the guidewire distal tip was separated from the body of the wire and left in the distal diagonal vessel.A non-abbott catheter was inserted over the viperwire guidewire flex tip and then it was noticed that the catheter was next to the viperwire guidewire tip.At this point, the physician realized that the tip of the wire was separated.The end of viperwire coronary guidewire had sheared off in distal lad near apex and approximately 30 mm radio plaque tip of the guidewire was left in-vivo.A non-abbott wire was inserted wire though the non-abbott catheter and the procedure was continued using a 2.25x18 skypoint stent, and more proximal a 2.5 x 15 skypoint stents.Post dilation was performed using a 2.0 x 15 sapphire balloon.The decision was made to leave the wire tip in place as the risks outweighed the benefits.There were no adverse patient effects due to wire dislodging.The patient is stable.

• 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 ; 6517562718
• MDR Report Key: 25374158
• Report Number: 3004742232-2026-00138
• Device Sequence Number: 21197980
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)271130(10)592377-1
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 592377-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White