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

Model Number	DBP-200SOLID145
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/05/2018
Type of Reportable Event	Serious Injury
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
During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), the crown of the device became detached and remained in the patient.The target lesion was treated with one pass of the oad on low speed.When the device was operated back through the lesion, it became stuck on the guide wire.The crown was advance forward and the device was turned on in attempt to detach from the wire, however the device shut off.The guide wire and device were removed from the sheath together, however it was noted that the crown had become detached and remained in the iliac.An attempt was made to snare the crown but was unsuccessful.The crown was secured to the vessel wall using covered stents and there were no additional complications reported.
Additional Manufacturer Narrative
The reported oad was received for analysis along with the guide wire utilized during the procedure.The crown and tip bushing were confirmed to be detached and were not returned.Scanning electron microscopy was performed and identified fatigue striations and secondary damage on the surface of the fractured driveshaft.This indicates that the driveshaft was subjected to torsional forces which resulted in a fatigue fracture.A kink and significant surface wear were observed on the returned guide wire.It is possible that the oad was spun over the kinked guide wire during the procedure, which may have led to the fracture.However, the exact cause of the fracture was unable to be determined by the device analysis.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.(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; saint paul MN 55112
• MDR Report Key: 8009376
• Report Number: 3004742232-2018-00315
• Device Sequence Number: 11151109
• Product Code: MCW
• UDI-Device Identifier: 10852528005275
• UDI-Public: (01)10852528005275(17)200731(10)233334
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: 07/31/2020
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: DBP¿200SOLID145
• Device Lot Number: 233334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 11/21/2018
• 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: 83 YR
• Patient Weight: 86