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

Model Number GWC-12325LG-FT

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

The guide wire was returned without the fractured spring tip section to csi for analysis.Visual examination confirmed the guide wire was fractured.Scanning electron microscopy of the guide wire core fracture revealed rotational and torsion marks, which indicated torsional forces were applied to the wire resulting in the fracture.This damage was consistent with fractures where the oads spun into the spring tips.At the conclusion of the analysis, the report that the guide wire fractured was confirmed.The root cause of the oad making contact with the spring tip was determined to be user error.The instructions for use of the coronary diamondback orbital atherectomy system state "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.Patient age is approximate, they are in their 80's.(b)(4).

Event Description

A viperwire guide wire was advanced into the circumflex artery (cx) via femoral approach.The heavily calcified target lesion was located on the proximal side of the cx, was 90% stenosed and had a vessel diameter of 2.75mm.During use, the orbital atherectomy device (oad) appeared to get close to the tip of the guide wire, which was located in the second obtuse marginal artery (om2).Upon removal it was noted that the radiopaque portion of the guide wire remained in the om2.The treatment area was stented.The fragment remained in vivo since the physician determined that an attempt to remove it may cause vessel damage.

• 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 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 9496305
• MDR Text Key: 172039064
• Report Number: 3004742232-2019-00335
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)210131(10)257537
• 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: 12/19/2019

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: 01/31/2021
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 257537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2019
• 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): Other
• Patient Age: 80 YR