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

Model Number	DBP-125SOLID145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).
Event or Problem Description
A diamondback peripheral orbital atherectomy device (oad) was selected for treatment of a severely calcified lesion in the proximal anterior tibial artery.During proximal to distal treatment, unexpected movement was observed, and a small piece of material was present in the vessel as seen on imaging.The oad was removed, and a second oad was used to complete the procedure.In the physician's opinion, the fragment was small and insignificant, so no attempt to retrieve the fragment was made.No additional patient adverse events were reported.
Additional Manufacturer Narrative
The reported oad was received for analysis.It was observed that the crown had detached and migrated proximally.Although the crown had migrated, there were no device fragments observed to be missing from the returned oad.The crown and solder bond were analyzed using scanning electron microscopy (sem).Sem showed a sufficient presence of solder indicating the crown had been attached.It is hypothesized that the device was spun in a high-stress environment causing the solder to reflow and eventually fail.However, the exact root cause of the detached crown was undetermined.A guide wire passed through the oad driveshaft and handle without issue.The oad spun on all speeds and functioned as intended.At the conclusion of the device analysis, the reported event of a foreign piece of material was unable to be conclusively confirmed.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.B1/h1: the event was initially reported as a serious injury.Analysis of the device conclusively confirmed that there were no components or fragments missing from the device.Therefore, the event no longer meets the criteria of a serious patient injury and is classified as a malfunction.Csi id# (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 11279825
• Report Number: 3004742232-2021-00029
• Device Sequence Number: 17071532
• Product Code: MCX
• UDI-Device Identifier: 10850000491189
• UDI-Public: (01)10850000491189(17)220228(10)313027
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

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: 02/28/2022
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: 7-10057-02
• Device Lot Number: 313027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 82