MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE); PERIPHERAL ATHERECTOMY DEVICE (GUIDE WIRE)

Model Number VPR-GW-FLEX14

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.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.Cause traced to user: the physician stated that the crown of the oad came too close to the spring tip of the viperwire since the patient's previous amputation did not leave adequate room for distal placement of the viperwire.The diamondback360® peripheral orbital atherectomy system instructions for use manual 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." csi id:(b)(4).

Event Description

A viperwire guide wire was selected for use via contralateral approach with right groin access.Several atherectomy treatments were administered in the left superficial femoral artery (sfa) and popliteal artery on low, medium, and high speed.Angioplasty was then performed.Imaging was performed, and the images showed the distal portion of the viperwire had fractured.Unsuccessful attempts were made to retrieve the fragment with a balloon and with two filters.Physician opinion was that it was best to abandon the fragment and deploy a stent over it to prevent future migration.At post-procedure review, the physician determined that some of the distal atherectomy treatments had been performed too close to the tip of the wire.The patient had previously undergone a below the knee amputation, and the amount of space available for wire placement was limited.The patient was stable following the procedure.

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE (GUIDE WIRE)
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul, mn
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul, mn
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, mn
• MDR Report Key: 10219764
• MDR Text Key: 201232696
• Report Number: 3004742232-2020-00186
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005718
• UDI-Public: (01)10852528005718(17)211231(10)308938
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: VPR-GW-FLEX14
• Device Catalogue Number: 7-10041-03
• Device Lot Number: 308938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR