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 Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/12/2020

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.(b)(4).

Event Description

During a procedure, a csi peripheral orbital atherectomy device (oad) and viperwire guide wire were used to treat lesions located in the superficial femoral (sfa) and popliteal arteries, which were 85-90% stenotic.The lesions were initially wired with non-csi guide wires, and an exchange was performed for the viperwire.Three treatment passes were performed in each lesion, the oad was removed, and imaging showed the tip of the viperwire guide wire had fractured.The user stated the oad had not spun near the spring tip of the viperwire.The lesions were ballooned, and the vessels had good flow through the posterior tibial (pt) artery.The fractured portion of the viperwire had migrated down the leg, and it was determined that the vessel was too small to attempt retrieval.Since there was good flow, the fragment was abandoned in the vessel.The patient was discharged home on (b)(6) 2020.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h3, h6, h10.The reported guide wire was received for analysis.The guide wire was fractured, and the fragment was not returned.Adhered adhesive residue from the proximal strain relief was proximal to the fracture site.Two kinks were observed, and there was rotational surface wear on one of the kinks.Scanning electron microscopy revealed the guide wire fractured, due to excessive torsional forces.This damage was consistent with the spinning oad driveshaft making contact with the spring tip.The root cause of the guide wire fracture was considered user error from spinning into the spring tip.The oas instructions for use states, "never advance the orbiting crown to the point of contact with the guide wire spring tip.Distal spring tip detachment and embolization may result.Make sure there is a minimum of 10 cm between the guide wire spring tip and the distal end of the shaft".At the conclusion of the device analysis, the reported event of a guide wire fracture was confirmed.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.Csi id# (b)(6).

• 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
• MDR Report Key: 10245758
• MDR Text Key: 197965836
• Report Number: 3004742232-2020-00191
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005718
• UDI-Public: (01)10852528005718(17)211231(10)306964
• 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: 07/17/2020

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
• 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: 306964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 77