MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE

Model Number C-2DB-CL125-135

Device Problems Unintended System Motion (1430); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2023

Event Type  malfunction  

Event Description

The diamondback 360 coronary orbital atherectomy device (oad) was used for treatment in the heavily calcified left circumflex artery/left main coronary artery (lcx/lm).Several treatments, proximal to distal and distal to proximal, were performed.The oad was observed to have jumped distally.During retrograde preparation, the oad fractured proximal to the oad crown.The fractured component was successfully removed with the viperwire advanced guide wire with no required intervention.Angioplasty and stent placement were performed to complete the procedure.The patient was stable and did not experience any complications due to the reported event.

Manufacturer Narrative

The investigation is ongoing.Once the investigation is completed a supplemental report will be submitted.Csi id: (b)(4).

Manufacturer Narrative

Additional information: d9, h3, h6 the guidewire was returned to csi for analysis.Visual inspection confirmed the guide wire was fractured at the proximal spring tip solder bond.Scanning electron microscopy analysis of the fracture faces revealed evidence of nitinol fatigue.This can occur when the oad spins too closely to the spring tip which contributes to fatigue forces on the core wire that can result in a fracture.The exact root cause of the guide wire fracture was unable to be determined.Csi id: (b)(4).

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h6, h10 the oad was returned with the driveshaft fractured at the distal edge of the crown.Scanning electron microscopy (sem) was performed on the fractured driveshaft sections.Driveshaft flexing at the weld location can initiate fatigue failure, and sem analysis identified fatigue striations at the site of the driveshaft fracture.This type of damage is seen when the driveshaft undergoes excessive flexing near the crown due to spinning in excessive tortuosity or resistance that pushed the driveshaft into a tight bend shape.Further review also found that the total spin time was longer than the 5 minute maximum which the instructions for use (ifu) notes and warns maximun total treatment time should not exceed 5 minutes.If maximum total treatment time exceeds 5 minutes, the oad shaft, crown, and viperwire guide wire may begin to exhibit signs of wear and result in a device malfunction and possible injury to patient.However, the root cause of the driveshaft fracture could not be conclusively determined.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Csi id: (b)(6).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: poonoy chanthavongsa ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18142978
• MDR Text Key: 328513618
• Report Number: 3004742232-2023-00278
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491417
• UDI-Public: (01)10850000491417(17)250228(10)473490-1
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: C-2DB-CL125-135
• Device Catalogue Number: 7-10060-03
• Device Lot Number: 473490-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 01/29/2024; 01/05/2024
• Supplement Dates FDA Received: 01/31/2024; 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 77 KG