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

Model Number	PRD-SC30-200
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	04/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(6).
Event or Problem Description
The diamondback peripheral orbital atherectomy device (oad) stopped spinning and became stuck in a highly calcified lesion in the superior femoral artery.The guide catheter, which was already in vivo, was advanced over the crown to free the oad.The procedure was abandoned.There were no patient complications.
Additional Manufacturer Narrative
Failure analysis conclusion: the oad was returned to csi for analysis with a competitor catheter.The device operated as intended during functional testing.The outer diameter of the crown met specifications.No abnormalities were identified with the crown that would have contributed to the device becoming stuck in the vessel.At the conclusion of the failure analysis investigation the stuck-in-lesion event was not confirmed.Analysis also identified the saline sheath had sustained a melted hole.A driveshaft filar was deformed and fractured in this area.Scanning electron microscopy analysis of the fractured filar faces could not conclusively confirm what caused the damage.The competitor catheter was kinked, which created resistance while removing the driveshaft crown section.The saline sheath and driveshaft damage may be the result of localized, elevated stress levels applied to the saline sheath and driveshaft while spinning.It is possible that the damage identified on the oad occurred as a result of the damage at the distal end of the competitor catheter.However, this could not be confirmed.The exact root cause of the sheath and shaft damage was unable to be determined.Csi id: (b)(4).

• 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; st. paul MN 55112
• MDR Report Key: 8633881
• Report Number: 3004742232-2019-00143
• Device Sequence Number: 16628315
• Product Code: MCW
• UDI-Device Identifier: 10852528005053
• UDI-Public: (01)10852528005053(17)211031(10)242740
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/28/2019

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: 10/31/2021
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 70056-06
• Device Lot Number: 242740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1