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

Model Number	DBP-200CLASS145
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/01/2018
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 located in the superficial femoral artery.Following treatment with the oad, the device was turned off and it was noted that the crown was detached and located distal to the end of the device.An attempt was made to retrieve the crown, however the snare was not able to traverse the vessel.The crown migrated to the anterior tibial artery and remained in the patient.The patient was in stable condition following the procedure.
Additional Manufacturer Narrative
The reported oad was received for analysis.The driveshaft was found to be elongated and stretched, and the crown was noted to be missing.No adhered biological material was observed on the driveshaft, and no evidence of driveshaft overloading was found.There was no additional damage observed to the oad, and when tested it functioned as intended.At the conclusion of the device analysis investigation, the reported event was confirmed.However, the root cause of the event was unable to be 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.

• 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: 7798342
• Report Number: 3004742232-2018-00255
• Device Sequence Number: 11317316
• Product Code: MCW
• UDI-Device Identifier: 10852528005268
• UDI-Public: (01)10852528005268(17)200531(10)228250
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 09/14/2018

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: 05/31/2020
• Device Model Number: DBP-200CLASS145
• Device Catalogue Number: DBP¿200CLASS145
• Device Lot Number: 228250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 09/14/2018
• 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: Other; Required Intervention