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

Model Number	DBEC-125
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/20/2025
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.The additional viperwire coronary advance flextip guide wire referenced in b5 is filed under separate medwatch report number.
Event or Problem Description
It was reported that during atherectomy procedure in a highly tortuous and heavily calcified right coronary artery (rca), the viperwire coronary advance flextip guidewire was positioned well distal to the crown, and the procedure was being performed slowly with the appropriate pauses.Due to the severe tortuosity and calcification of the artery, the guidewire fractured, and the radiopaque tip detached and migrated distally in the artery.Three treatments were performed prior to guidewire fracture.In addition, part of the crown of the diamondback 360 coronary orbital atherectomy device (oad) detached and migrated into the bloodstream.The entire tip of the oad fractured.The physician removed the system from the patient and repaired the lesion with a stent.After the lesion was treated, an attempt was made to capture the wire tip using a snare, and later by applying torque with another wire to try to coil and retrieve it into the catheter.After several unsuccessful attempts, the radiopaque tip of the viperwire was left in-vivo to avoid arterial injury or a potential perforation that could occur if other retrieval methods were used.The physician left the radioopaque tip of the guidewire in-vivo as the patient was on multiple anticoagulants and did not see a major risk in leaving the fragment in place.It was noted that the oad did not make contact with the spring tip and there was a possibility of wire bias since the artery had a curve.The patient was stable.
Event or Problem Description
It was reported that during atherectomy procedure in a highly tortuous and heavily calcified right coronary artery (rca), the viperwire coronary advance flextip guidewire was positioned well distal to the crown, and the procedure was being performed slowly with the appropriate pauses.Due to the severe tortuosity and calcification of the artery, the guidewire fractured, and the radiopaque tip detached and migrated distally in the artery.Three treatments were performed prior to guidewire fracture.In addition, part of the crown of the diamondback 360 coronary orbital atherectomy device (oad) detached and migrated into the bloodstream.The entire tip of the oad fractured.The physician removed the system from the patient and repaired the lesion with a stent.After the lesion was treated, an attempt was made to capture the wire tip using a snare, and later by applying torque with another wire to try to coil and retrieve it into the catheter.After several unsuccessful attempts, the radiopaque tip of the viperwire was left in-vivo to avoid arterial injury or a potential perforation that could occur if other retrieval methods were used.The physician left the radioopaque tip of the guidewire in-vivo as the patient was on multiple anticoagulants and did not see a major risk in leaving the fragment in place.It was noted that the oad did not make contact with the spring tip and there was a possibility of wire bias since the artery had a curve.The patient was stable.
Additional Manufacturer Narrative
A visual inspection, functional testing and detailed analysis were performed on the returned device.The reported material separation resulting in foreign body in patient is 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 circumstances of the procedure.Detailed analysis of the driveshaft fracture revealed evidence of fatigue failure indicating that the fracture occurred while spinning in an elevated stress environment.This is consistent with complaint details which describe the treatment area as highly tortuous and heavily calcified.The cause of the stress condition that led to the fracture is unknown.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: d9, g3, g6, h2, h3, h6 (component code, 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: 23789649
• Report Number: 3004742232-2025-00371
• Device Sequence Number: 10471028
• Product Code: MCX
• UDI-Device Identifier: 10850026568698
• UDI-Public: (01)10850026568698(17)270831(10)583045-1
• Combination Product (Y/N): N
• 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): 01/29/2026

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: DBEC-125
• Device Catalogue Number: 7-10098-01
• Device Lot Number: 583045-1
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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