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

Model Number	VPR-GW-FLEX18
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported oad and guide wire were received for analysis.The guide wire was not engaged in the device.A fracture was observed at the proximal solder bond of the guide wire.The spring tip fragment was not returned.Scanning electron microscopy of the fracture face revealed torsional damage.This damage was likely caused from the spinning oad making contact with the guide wire spring tip.The root cause of the guide wire fracture was hypothesized to be user error.The diamondback 360 peripheral orbital atherectomy system instructions for use states, "when moving the crown advancer knob, make sure there is sufficient distance between the guide wire spring tip and the distal end of the shaft (10 cm minimum).If the distance between the shaft tip and the guide wire spring tip is insufficient, the shaft tip may damage the guide wire spring tip and result in dislodgement of the guide wire spring tip.Use contrast injections and fluoroscopy to monitor movement of the shaft tip in relation to the guide wire spring tip." no damage was observed on the oad.A guide wire passed through the oad with no resistance, and the oad functioned as intended when tested.At the conclusion of the device analysis, the reported guide wire fracture 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.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 procedure, a 1.5 solid diamondback peripheral orbital atherectomy device (oad) and viperwire guide wire were selected for use for a mid to distal peroneal lesion.The vessel was approximately two (2) millimeters in diameter.The lesion was treated with five passes on low speed.The oad was removed.When the balloon was placed for angioplasty, it was observed that the guide wire spring tip had fractured.The fragment was approximately two (2) centimeters long.As the fragment was distal and the outflow was good, the physician elected to abandon the fragment and did not attempt to snare it.Additional angioplasty of the lesion was performed.The physician stated the vessels in the lower leg were improved compared to the start of the procedure.The patient was admitted to the hospital following the procedure for a previously planned amputation of the great toe.

• 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
• MDR Report Key: 10347279
• Report Number: 3004742232-2020-00222
• Device Sequence Number: 3416818
• Product Code: MCW
• UDI-Device Identifier: 10852528005725
• UDI-Public: (01)10852528005725(17)211231(10)301491
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• 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): 07/30/2020

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: 12/31/2021
• Device Model Number: VPR-GW-FLEX18
• Device Catalogue Number: 7-10041-04
• Device Lot Number: 301491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/30/2020
• 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