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

Model Number	DBP-200CLASS145
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported oad was received for analysis with the guide wire engaged in the device.The device driveshaft and saline sheath and the guide wire were found to have been destructively cut.The driveshaft was elongated in the area of the crown solder bond and the crown was detached and missing.Scanning electron microscopy was performed and did not identify any issue with the solder bond which may have contributed to the detachment.It was reported to csi that the location of the crown was unknown.When tested, the oad spun on all speeds as intended.At the conclusion of the device analysis investigation, the reported inability to cross the lesion was unable to be confirmed.Additionally, the cause of the crown detachment could not be conclusively 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.(b)(4).
Event or Problem Description
During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), the device became stuck in the lesion resulting in a procedural delay.The target lesion was 90% stenosed and located in the popliteal.During treatment of the lesion, the device stalled and became stuck in the lesion.The oad was disassembled and a guide catheter was inserted in order to remove the device, resulting in a one hour procedural delay.The lesion was re-wired and the procedure was completed with balloon angioplasty.The patient was in stable condition following the procedure.

• 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: 7687059
• Report Number: 3004742232-2018-00210
• Device Sequence Number: 1398173
• Product Code: MCW
• UDI-Device Identifier: 10852528005268
• UDI-Public: (01)10852528005268(17)200331(10)220845
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 07/13/2018

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: 03/31/2020
• Device Model Number: DBP-200CLASS145
• Device Catalogue Number: DBP¿200CLASS145
• Device Lot Number: 220845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 91