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

Model Number	VPR-GW-FT14
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted after the device analysis is completed.(b)(4).
Event or Problem Description
Six treatments with the orbital atherectomy device were performed in the superficial femoral artery following failed delivery of the viperwire to the tibial artery after several attempts.During the attempts to deliver the wire to the tibial artery, the wire had folded several times.The tip of the wire broke off in situ near the aortic bifurcation during retraction, and a snare was used to remove the fragment.The patient was discharged as planned following the procedure.Approach for the procedure was contralateral, and the vessel was 80% stenotic with a type b lesion.
Additional Manufacturer Narrative
The guide wire and spring tip were returned to csi for investigation with a fracture in the core located just proximal from the spring tip.Both the proximal and distal segments of the guide wire were returned.The wire core was deformed with a small radius bend at the fracture location, consistent with having been kinked prior to fracture.Scanning electron microscopy analysis revealed the presence of torsional stresses on the fracture faces of the core wires.However, the exact root cause of the fracture could not be determined.At the conclusion of the failure analysis investigation the event was confirmed.The ifu contains the following warnings: "handle the oad and guide wire carefully.A tight loop, kink, or bend in the guide wire may cause damage and system malfunction during use." and "a prolapsed or bent guide wire core can result in damage to the guide wire or oad." 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).

• 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: 7998775
• Report Number: 3004742232-2018-00312
• Device Sequence Number: 19177757
• Product Code: MCW
• UDI-Device Identifier: 10852528005312
• UDI-Public: (01)10852528005312(17)190630(10)198255
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K151260
• 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): 10/29/2018

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: 06/30/2019
• Device Model Number: VPR-GW-FT14
• Device Catalogue Number: VPR-GW-FT14
• Device Lot Number: 198255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 82