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

Model Number	DBP-125MICRO145
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).
Event or Problem Description
A diamondback peripheral orbital atherectomy device (oad) was used to engage a 90% stenosed, severely calcified lesion in the anterior tibial artery.The crown of the oad became stuck in the lesion twice, and on the third treatment attempt the driveshaft fractured at the proximal side of the crown.The oad fragment remained on the guide wire and was able to be removed from the patient without additional intervention.Another oad was used to complete the procedure with a good result.
Additional Manufacturer Narrative
The oad was received at csi for analysis.A visual examination determined that the oad was not fractured near the crown, but near the handle of the oad at the lap weld.Scanning electron microscopy was performed at the fracture site and showed evidence of torsion.This type of damage is consistent with spinning the device into an extremely tight lesion with excessive force and overloading to fracture.However, this was not confirmed, and the root cause of the driveshaft fracture remains undetermined.When tested the device functioned as intended.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 prior to distribution.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• MDR Report Key: 11148004
• Report Number: 3004742232-2021-00006
• Device Sequence Number: 3607178
• Product Code: MCW
• UDI-Device Identifier: 10850000491172
• UDI-Public: (01)10850000491172(17)220331(10)317472
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• 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): 01/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: 7-10057-01
• Device Lot Number: 317472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 108