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	12/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.(b)(4).
Event or Problem Description
The tip of the viperwire fractured in the posterior tibial artery during the procedure because the orbital atherectomy device was spun over the distal tip of the wire.The fragment could not be retrieved and was left in vivo.The procedure was completed with balloon angioplasty.
Additional Manufacturer Narrative
Failure analysis conclusion: the device was received at csi for anslysis.Analysis of the guide wire revealed the proximal core wire to be fractured located 332.5cm from the proximal end.There was some adhered biological material on the core shaft fracture site.The exact cause of the tissue accumulation could not be determined.The distal fractured spring tip section was not returned.Scanning electron microscopy revealed the presence of excessive torsional stresses on the fracture face of the core wire.The core gw fracture site exhibited grind marks with galling on the outer diameter.These findings are consistent with the reported event details which state, "the viperwire fractured during the procedure because the orbital atherectomy device was spun over the distal tip of the wire." therefore the root cause of the fracture is considered user error.At the conclusion of the failure analysis investigation the reported event was confirmed.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: 8276134
• Report Number: 3004742232-2019-00034
• Device Sequence Number: 158947
• Product Code: MCW
• UDI-Device Identifier: 10852528005312
• UDI-Public: (01)10852528005312(17)200131(10)216266
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 03/25/2019

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: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: VPR-GW-FT14
• Device Catalogue Number: VPR-GW-FT14
• Device Lot Number: 216266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2019
• Supplement Date Received by Manufacturer: 02/12/2019; 02/27/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 02/13/2019; 03/25/2019
• 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: Other