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

Model Number	DBP-150SOLID145
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device was returned for evaluation.The analysis of the device revealed the saline sheath and driveshaft to be damaged.Examination of the saline sheath and driveshaft revealed the driveshaft to be fractured in multiple places, some of which may have occurred outside the patient.Scanning electron microscope (sem) analysis identified the presence of fatigue on the fractured filars.The driveshaft damage is likely the result of localized, elevated stress levels applied to the driveshaft while spinning.Examination of the returned guide wire revealed the spring tip and the distal and proximal solder bonds to be intact and undamaged.There was no adhered biological material on the guide wire shaft or spring tip.Based on the results of the device analysis, the root cause of the sheath and shaft damage was unable to be determined.
Event or Problem Description
It was reported that during a peripheral orbital atherectomy procedure, the tip of the device became detached.During treatment of a calcified lesion in the superficial femoral artery, the csi orbital atherectomy device (oad) stopped functioning.During removal of the device, the crown was noted to have detached.All components were removed from the patient and the procedure was completed by balloon angioplasty.The patient condition was stable throughout the procedure.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; saint paul MN 55112
• MDR Report Key: 7042477
• Report Number: 3004742232-2017-00132
• Device Sequence Number: 2144876
• Product Code: MCW
• UDI-Device Identifier: 10852528005237
• UDI-Public: (01)10852528005237(17)190630(10)195165
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: DBP-150SOLID145
• Device Catalogue Number: DBP-150SOLID145
• Device Lot Number: 195165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/17/2017
• 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