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

Model Number GWC-12325LG-FT

Device Problems Material Separation (1562); Unintended Movement (3026)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/28/2020

Event Type  Injury  

Manufacturer Narrative

The reported guide wire was received for analysis.The guide wire was fractured, and the spring tip was not returned.Solder bond material was observed on the guide wire proximal to the fracture, and surface damage was observed.Scanning electron microscopy revealed rotational torsion marks on the core shaft of the guide wire.The fracture face showed tensile dimples.This damage was consistent with rotational damage that occurs when the oad driveshaft is spun into the guide wire spring tip, resulting in a fracture.It was hypothesized that the root cause of the fracture was user error.At the conclusion of the device analysis, the report of a guide wire fracture was confirmed.The instructions for use states, "do not come within 5 mm of the proximal end of the viperwire guide wire spring tip with the distal end of the oad drive shaft.If the distance between the shaft tip and the viperwire guide wire spring tip is insufficient, the shaft tip may contact the guide wire spring tip and result in dislodging the guide wire spring tip.Use fluoroscopy to monitor movement of the shaft tip in relation to the viperwire guide wire spring tip." 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)(4).

Event Description

During a procedure, the viperwire guide wire fractured.The 98% stenosed, highly calcified target lesion was located in an area of the proximal right coronary artery (rca) that was 3 millimeters in diameter.During the second treatment pass, the viperwire moved back while the oad was spinning, and the spring tip fractured.The brake lever of the oad was depressed.Unsuccessful attempts were made to remove the guide wire fragment, and the fragment was stented to the vessel wall.The procedure was completed with alternate atherectomy, percutaneous transluminal coronary angioplasty (ptca), and stent placement.The patient had a good clinical outcome and was scheduled for discharge on (b)(6) 2020.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer Contact: sarah hicks ; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 9876916
• MDR Text Key: 191585827
• Report Number: 3004742232-2020-00094
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)211130(10)298067
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• 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: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 298067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2019
• 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): Required Intervention
• Patient Age: 67 YR