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 Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).
Event or Problem Description
The viperwire was inadvertently advanced into a heavily calcified lesion in the anterior tibial (at) artery during advancement of a support catheter.The viperwire fractured and was left in vivo.Atherectomy was performed in the popliteal artery and was followed by balloon angioplasty for post-dilation.Slow flow was noted through the at artery.Attempts to remove the wire fragment were unsuccessful, and the procedure was prolonged by forty-five minutes.An additional 45cc of contrast and additional fluoroscopy were required due to the attempts.There were no additional patient complications, and the procedure was concluded.Reportedly, the popliteal to tibioperoneal trunk was severely calcified, as were the anterior tibial and posterior tibial vessels.
Additional Manufacturer Narrative
Failure analysis conclusion: examination of the guide wire revealed the proximal core wire to be fractured and curled up.The distal fractured spring tip section was not returned.Scanning electron microscopy (sem) analysis revealed the presence of ductile torsional stresses on the fracture faces of the core wires.Although the exact root cause of the guide wire fracture is undetermined, the sem analysis is consistent with an oad spinning over a tight bend or kink in the wire.At the conclusion of the failure analysis investigation the fracture event was 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).

• 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: 8370954
• Report Number: 3004742232-2019-00064
• Device Sequence Number: 16418531
• Product Code: MCW
• UDI-Device Identifier: 10852528005312
• UDI-Public: (01)10852528005312(17)201031(10)249690
• 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
• Report Date (Section B): 03/15/2019

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: 10/31/2020
• Device Model Number: VPR-GW-FT14
• Device Catalogue Number: VPR-GW-FT14
• Device Lot Number: 249690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 03/15/2019
• 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