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

Model Number	GWC-12325LG-FLP
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure, while placing the viperwire coronary guidewire in the patient, the guidewire entered the proximal left anterior descending (lad) artery where it became lodged in the nodular calcium, resulting in spring tip fracture.The entire radiopaque tip of the guidewire was left in the patient.The fractured component was entrapped with a non-abbott stent.Medication was administered to treat issue with the device.The vessel was primarily wired with the viperwire and no wire bias was reported.It was noted that the orbital atherectomy device was not inserted into the patient.The patient was stable.The physician has no concerns about long term patient risk outcomes.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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, entrapment of device, foreign body in patient, medication, and unexpected medical intervention appears to be related to operational context.In this case it is likely that the reported material separation, entrapment of device, foreign body in patient, medication, and unexpected medical intervention are a result of the patient¿s disease severity combined and/or 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.
Event or Problem Description
It was reported that during procedure, while placing the viperwire coronary guidewire in the patient, the guidewire entered the proximal left anterior descending (lad) artery where it became lodged in the nodular calcium, resulting in spring tip fracture.The entire radiopaque tip of the guidewire was left in the patient.The fractured component was entrapped with a non-abbott stent.Medication was administered to treat issue with the device.The vessel was primarily wired with the viperwire and no wire bias was reported.It was noted that the orbital atherectomy device was not inserted into the patient.The patient was stable.The physician had no concerns about long term patient risk outcomes.

• 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: 21950582
• Report Number: 3004742232-2025-00122
• Device Sequence Number: 8535026
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)250731(10)8617952
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/29/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 8617952
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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: Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 90 KG