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

Model Number	DBEC-125
Medical Device Problem Codes	Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for user manual states that treatment time should not exceed 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 adverse event that may occur and/or require intervention with use of the system.The oad was returned with the driveshaft crown detached and missing.Scanning electron microscopy (sem) was performed on the damaged driveshaft and analysis shows that the crown weld is present and adequately fused to the driveshaft.The tip bushing also exhibited evidence of rotational grinding.This type of damage and reduced diameter is consistent with spinning through significant resistance, such as tight calcified lesion.Review of the data log shows a stall event occurred.It is unknown if the stall event is related to the reported complaint.The data log also shows 9.08 minutes of total spin time and 1.73 minutes of total glide spin time, it is hypothesized the combination of spinning with force against resistance and the extended length of spin time contributed to the eventual crown detachment.This use of the device is not consistent with the instructions for use (ifu).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)(4).
Event or Problem Description
Following a difficult wire exchange for the viperwire advance guide wire, the diamondback 360 coronary orbital atherectomy device (oad) was used for treatment in a 3.5mm, 95% stenosed and heavily calcified left anterior descending artery (lad).Difficulty was experienced when advancing the oad and the oad could not cross the long diffused, heavily calcified lesion.15 spin attempts at 30 seconds were made to cross the lesion but were unsuccessful.The oad was removed and the diamond coating on the oad crown appeared to had been completely worn off.A new oad was not available onsite, causing the procedure to be aborted.The patient was sent to icu and given the option to try rotational atherectomy or bypass.During device analysis, it was identified the oad crown was detached.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: 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: 18614525
• Report Number: 3004742232-2024-00096
• Device Sequence Number: 2506197
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)241231(10)465841-1
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Report Date (Section B): 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 465841-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• 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: Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 70 KG