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

Model Number VPR-GW-FLEX14

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).

Event Description

A viperwire guide wire was used during atherectomy planned for the popliteal, peroneal, and posterior tibial (pt) arteries.The pt artery was occluded prior to treatment.The popliteal and peroneal arteries were treated first, and the orbital atherectomy device (oad) and wire were removed from the patient.The tip of the viperwire appeared worn, but it was used for additional treatment.The wire became bent in the distal pt artery near the level of the ankle.Aggressive treatment was performed on medium speed, and the oad jumped through a lesion.The driveshaft of the oad contacted the spring tip of the wire, and the wire fractured.The wire fragment was abandoned.The patient remained stable throughout the procedure and did not experience complications.The popliteal and peroneal arteries appeared open at the conclusion of the procedure, but the pt was still occluded.

Manufacturer Narrative

Device analysis conclusion: the oad and wire were returned for analysis.The fractured guide wire spring tip was lodged within the driveshaft tip bushing section, and the remaining core shaft was engaged in the oad.The distal end of the spring tip was not returned.The spring tip section was removed from the driveshaft and tip bushing.The core shaft was also removed with no further damage observed.Scanning electron microscopy analysis of the fracture showed that the wire fractured due to fatigue.There were radiopaque particles identified on the tip bushing of the oad, which is consistent with the report that the oad contacted the spring tip of the guide wire.The diamondback 360® peripheral orbital atherectomy system instructions for use manual warns, "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." at the conclusion of the device analysis investigation, the reported wire fracture was confirmed, and the root cause was determined to be user error.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 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 10936402
• MDR Text Key: 219324598
• Report Number: 3004742232-2020-00388
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005718
• UDI-Public: (01)10852528005718(17)220731(10)334650
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: VPR-GW-FLEX14
• Device Catalogue Number: 7-10041-03
• Device Lot Number: 334650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other