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

Model Number	VPR-GW-FT18
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported guide wire was received for analysis.A non-csi exchange catheter with the fractured guide wire spring tip engaged on the snare device was also received.Examination of the spring tip on the snare device revealed the core shaft to be fractured located 6 mm from the proximal solder bond.The spring tip coils were also damaged and deformed.Examination of the proximal guide wire core shaft revealed the proximal core wire to be fractured and curled up.There was no other damage revealed with the guide wire that would have contributed to the reported event.Scanning electron microscopy revealed the presence of torsional stresses on the fracture faces of the core wires.Although the root cause was not established, this type of damage is consistent with spinning over a tight bend or kink in the wire.Bench testing has found that if the distal guide wire core becomes kinked near the spring tip, additional manipulation and applied tensile forces on the guide wire can reduce the wire strength and result in fracture.The material inspection report for this guide wire 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).
Event or Problem Description
During a peripheral procedure, a non-csi filter was being used off of the viperwire guide wire.The target lesion was highly calcified, but not totally occluded, and located in the distal superficial femoral artery (sfa).After the lesion was treated successfully, an attempt was made to retrieve the filter, and the guide wire fractured.A retrieval catheter was used to snare the filter and guide wire fragment.No device fragments were left in the patient, however, some captured material was lost downstream.It was noted that there was no unusual strain on the guide wire, and the orbital atherectomy device (oad) was not close to the filter or the end of the guide wire at any time during the procedure.The procedure was completed with balloon angioplasty with no additional patient complications.It was noted that the posterior tibial artery was also successfully treated during the procedure.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 8460286
• Report Number: 3004742232-2019-00078
• Device Sequence Number: 16875455
• Product Code: MCW
• UDI-Device Identifier: 10852528005329
• UDI-Public: (01)10852528005329(17)200930(10)243573
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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
• Report Date (Section B): 03/28/2019

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: 09/30/2020
• Device Model Number: VPR-GW-FT18
• Device Catalogue Number: VPR-GW-FT18
• Device Lot Number: 243573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/28/2019
• 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: Required Intervention
• Patient Age: 60 YR