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

Model Number VPR-GW-FLEX14

Device Problem Material Separation (1562)

Patient Problems Skin Tears (2516); Device Embedded In Tissue or Plaque (3165)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

The initial guide wire fragment removed was received for analysis.The fragment was determined to be part of the core wire, and the spring tip was not returned.The guide wire was fractured at both ends of the returned fragment.Scanning electron microscopy identified that one end showed damage consistent with a fracture due to excessive fatigue.The other end of the guide wire exhibited surface wear and fatigue striations.The exact root cause of the fractures was undetermined however, there was no evidence of a design issue or that the guide wire had not met specifications.At the end of the device analysis, the reported event of a fractured guide wire was confirmed.The instructions for use state, "when advancing or removing the viperwire atherectomy guide wire, always use fluoroscopic guidance with radiographic equipment that provides high-resolution images.Never position the guide wire blindly, as this may result in misplacement, dissection or perforation.Since the oad tracks and operates over the guide wire, it is imperative to confirm by angiography that the guide wire is positioned within the vessel, at least 10 cm distal to the target stenosis, and that the wire is not within a false lumen." 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.The guide wire fragment removed from the patient on (b)(6) 2019 was received for analysis on 6-dec-2019.A supplemental report will be submitted when the device analysis is completed.(b)(4).

Event Description

Orbital atherectomy with a csi orbital atherectomy device (oad) and viperwire guide wire had been performed at a peripheral procedure on (b)(6) 2019.The target lesion for the procedure was very tight and the lesion was heavily calcified.Final imaging at the procedure was performed prior to the guide wire being removed, and the staff did not notice any fracture in the guide wire when it was removed.At some point after the procedure, the patient developed a blister on the lateral side of their leg approximately 4-6 inches below their knee.A small piece of metal was seen in the blister, and a large section of a guide wire was removed from the blister which was thought to be part of the viperwire.The removed guide wire did not contain the distal tip of the wire.An x-ray was performed, and an additional fragment was still located in the patient's leg from above the popliteal artery down through the perineal artery in the same position a wire would have been during a procedure.The wire appeared to be intraluminal, and no breaks or fractures were seen in the wire from the x-ray.It was noted that the patient had no additional procedure between the orbital atherectomy on (b)(6) 2019 and when the device fragments were found in the blister.On (b)(6) 2019, a procedure was performed to assess the remaining wire fragment and remove it if possible.The remaining wire fragment was unable to be retrieved, and the tip of the wire was found to be embedded in the vessel wall.The wire was not causing any issues or symptoms in the patient.On (b)(6) 2019, a surgical procedure was performed to remove the remaining wire.The popliteal artery was opened right below the knee of the patient, and a segment of wire was removed.Imaging performed after the surgery showed a small amount of wire remained in the ankle.The patient tolerated the procedure well and was in stable condition immediately following the procedure.The patient was discharged the day following the procedure with no complications.

Manufacturer Narrative

The second guide wire fragment removed was received for analysis.The fragment was determined to be core wire with part of the strain relief, and the spring tip was not returned.Two kinks were observed on the guide wire fragment.The guide wire was fractured at both ends of the returned fragment.Scanning electron microscopy identified that both ends showed fatigue striation damage consistent with a fracture due to excessive fatigue.The exact root cause of the fractures and kinks were undetermined however, there was no evidence of a design issue or that the guide wire had not met specifications.At the end of the device analysis, the reported event of a fractured guide wire was confirmed.(b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 9438780
• MDR Text Key: 183108350
• Report Number: 3004742232-2019-00317
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005718
• UDI-Public: (01)10852528005718(17)210531(10)272811
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: VPR-GW-FLEX14
• Device Catalogue Number: 7-10041-03
• Device Lot Number: 272811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 147