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

Model Number	DBP-200CLASS145
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported oad was received for analysis with the guide wire.Upon visual examination, adhered biological material was found on the driveshaft and crown.The morphology of the material is unknown.The driveshaft and sheath were found to have been destructively cut from the oad handle.The returned guide wire was also cut.No damage was found on the device which would have contributed to the reported event.When tested, the device functioned as intended and did not stall or emit any unusual noises.At the conclusion of the device analysis investigation, the reported event was unable to be 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.Csi id#: (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 a total occlusion and was located in the superficial femoral artery (sfa).During atherectomy treatment, the oad made an abnormal noise and became stuck in the lesion and stalled.The crown would not retract into the sheath, and a larger sheath was inserted in order to remove the oad.This resulted in a procedure delay of one hour.The procedure was then completed with balloon angioplasty and the patient was in stable condition.

• 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: 7667153
• Report Number: 3004742232-2018-00198
• Device Sequence Number: 1040950
• Product Code: MCW
• UDI-Device Identifier: 10852528005268
• UDI-Public: (01)10852528005268(17)200131(10)213923
• 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): 07/06/2018

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: 01/31/2020
• Device Model Number: DBP-200CLASS145
• Device Catalogue Number: DBP¿200CLASS145
• Device Lot Number: 213923
• 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: 06/07/2018
• Initial Report FDA Received Date: 07/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 43