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

Model Number	GWC-12325LG-FT
Medical Device Problem Codes	Unintended System Motion (1430); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
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 that during procedure to treat heavily calcified, heavily tortuous lesion in left anterior descending artery (lad) a non-abbott guide wire and microcatheter were used to gain access then exchanged for a viperwire advance coronary guide wire with flex tip.While advancing the diamondback 360 precision coronary orbital atherectomy device (oad) to the lesion on glideassist, the viperwire came back due to the tortuosity.There was significant wire bias.There was difficulty wiring or delivering devices.The oad and viperwire did not make contact.The viperwire was accidentally pulled through the back of the oad.The physician proceeded to remove the viperwire and felt resistance at the oad driveshaft and then stuck to the oad and removed it which resulted in the distal radiopaque spring tip fracturing.The fractured component was snared successfully.The viperwire was replaced to complete the procedure with the same oad.There were no issues reported on the oad guide wire brake or control knob.There was no driveshaft damage.The patient was stable.The physician has no concerns about potential long-term risk outcomes.
Event or Problem Description
It was reported that during procedure to treat heavily calcified, heavily tortuous lesion in left anterior descending artery (lad) a non-abbott guide wire and microcatheter were used to gain access then exchanged for a viperwire advance coronary guide wire with flex tip.While advancing the diamondback 360 precision coronary orbital atherectomy device (oad) to the lesion on glideassist, the viperwire came back due to the tortuosity.There was significant wire bias.There was difficulty wiring or delivering devices.The oad and viperwire did not make contact.The viperwire was accidentally pulled through the back of the oad.The physician proceeded to remove the viperwire and felt resistance at the oad drive shaft and then stuck to the oad and removed it which resulted in the distal radiopaque spring tip fracturing.The fractured component was snared successfully.The viperwire was replaced to complete the procedure with the same oad.There were no issues reported on the oad guide wire brake or control knob.There was no driveshaft damage.The patient was stable.The physician has no concerns about potential long-term risk outcomes.
Additional Manufacturer Narrative
A visual inspection and dimensional analysis were performed on the returned device.The reported material separation was confirmed.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 reported information and the observations from the returned analysis, the investigation determined that the reported material separation appears to be related to user error.Per complaint details, the guide wire fracture is due to the physician accidently pulling the guide wire proximally through the oad causing contact of the spring tip and the driveshaft tip bushing.The diamondback 360® coronary orbital atherectomy system instruction for use (ifu), warns: ¿use fluoroscopy to monitor and maintain spacing between the driveshaft and guide wire spring tip throughout the procedure.Always keep more than 5mm of spacing between the distal end of the oad driveshaft and the proximal end of the guide wire spring tip.If the distance between the driveshaft tip and the viperwire guide wire spring tip is insufficient, the driveshaft tip may contact the guide wire spring tip and result in dislodging the guide wire spring tip.¿ 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: g3, g6, h2, h3, h6 [(codes 4755, 4118, 3233, and 11 no longer apply), (code 2017 added)].

• 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, #3008814558; 14740 kirby dr; houston TX 77047
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 23728758
• Report Number: 3004742232-2025-00364
• Device Sequence Number: 18444334
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)270630(10)576864-1
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/12/2026

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: 576864-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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 Sex: Unknown