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 Codes	Cardiac Arrest (1762); Tachycardia (2095); Perforation of Vessels (2135); Foreign Body In Patient (2687); Pericardial Effusion (3271)
Date of Event	02/23/2026
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 right and left femoral access was obtained to place a non-abbott device prior to start of the procedure.Heparin was used for anticoagulation and activated clotting times (acts) were confirmed therapeutic and monitored.A non-abbott wire was placed into the left anterior descending (lad) artery and exchanged over 2.0 otw balloon for the viperwire coronary guidewire.A diamondback coronary orbital atherectomy device (oad) was used with a viperwire coronary guidewire during atherectomy procedure to treat 80% stenosed heavily calcified circumflex artery.Orbital atherectomy was completed from the left main (lm) to proximal lad successfully.The viperwire guidewire was removed and a non-abbott wire was advanced into the distal left circumflex.It was then exchanged for the viperwire guidewire via a twin pass catheter.Atherectomy was performed in the proximal circumflex.The tip of the wire was sheared off into the distal left circumflex.3 cm of the wire was left in-vivo.Attempting to rewire the left circumflex in order to capture the wire or stent it against the wall was difficult.The patient experienced tachycardia and unstable leading to pulseless electrical activity (pea) arrest.Advanced cardiovascular life support (acls) protocol was completed for approximately 15 minutes.Emergent transthoracic echocardiogram showed moderate to large pericardial effusion.An emergent pericardiocentesis was performed.During procedure, the circumflex was perforated.A non-abbott 3.0x15 covered stent was then placed in left circumflex to treat the perforation and capturing the wire so that it was not free floating.Ivus was performed for stent sizing of the lad/left main and then following the circumflex for stenting of the lesions.Post angiography revealed no further flow via the perforation.In the opinion of the physician, the wire breaking off did cause the oad to perforate the vessel.It was noted that there was some wire bias due to an area of tortuosity down the mid to distal circumflex.The patient was stable.
Event or Problem Description
It was reported that right and left femoral access was obtained to place a non-abbott device prior to start of the procedure.Heparin was used for anticoagulation and activated clotting times (acts) were confirmed therapeutic and monitored.A non-abbott wire was placed into the left anterior descending (lad) artery and exchanged over 2.0 otw balloon for the viperwire coronary guidewire.A diamondback coronary orbital atherectomy device (oad) was used with a viperwire coronary guidewire during atherectomy procedure to treat 80% stenosed heavily calcified circumflex artery.Orbital atherectomy was completed from the left main (lm) to proximal lad successfully.The viperwire guidewire was removed and a non-abbott wire was advanced into the distal left circumflex.It was then exchanged for the viperwire guidewire via a twin pass catheter.Atherectomy was performed in the proximal circumflex.The tip of the wire was sheared off into the distal left circumflex.3 cm of the wire was left in-vivo.Attempting to rewire the left circumflex in order to capture the wire or stent it against the wall was difficult.The patient experienced tachycardia and unstable leading to pulseless electrical activity (pea) arrest.Advanced cardiovascular life support (acls) protocol was completed for approximately 15 minutes.Emergent transthoracic echocardiogram showed moderate to large pericardial effusion.An emergent pericardiocentesis was performed.During procedure, the circumflex was perforated.A non-abbott 3.0 x 15 covered stent was then placed in left circumflex to treat the perforation and capturing the wire so that it was not free floating.Ivus was performed for stent sizing of the lad/left main and then following the circumflex for stenting of the lesions.Post angiography revealed no further flow via the perforation.In the opinion of the physician, the wire breaking off did cause the oad to perforate the vessel.It was noted that there was some wire bias due to an area of tortuosity down the mid to distal circumflex.The patient was stable.
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 material separation, cardiac arrest, foreign body in patient, tachycardia, perforation of vessels, pericardial effusion and unexpected medical intervention appears to be related to operational context.In this case, it is possible that the reported material separation, cardiac arrest, foreign body in patient, tachycardia, perforation of vessels, pericardial effusion and unexpected medical intervention are due to patient disease state and/or use techniques employed; however, since the device was not returned this cannot 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) and h11.

• 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, #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: 24933512
• Report Number: 3004742232-2026-00097
• Device Sequence Number: 18808423
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)261130(10)557819-1
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 05/28/2026

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: 557819-1
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2024
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White