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); Malposition of Device (2616)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/07/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.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.(b)(4).

Event Description

During a procedure, the coronary viperwire guide wire fractured.The 90% stenosed, severely calcified target lesion was located in an area of the left circumflex artery from location #11 to location #12.The vessel was 3.0mm in diameter.The spring tip of the guide wire was placed at location #12, distal to the target lesion.During treatment, the driveshaft of the csi orbital atherectomy device (oad) was reported to have contacted the guide wire spring tip, and the spring tip fractured.It was noted that the crown of the oad was difficult to see under fluoroscopy, and the physician was unaware that the crown advanced past the lesion.The oad driveshaft was already in contact with the guide wire spring tip when the position of the crown was noticed.The fractured spring tip was located in a small distal side branch of an obtuse marginal (om), and attempts to snare the fragment resulted in it moving deeper into the om.The physician abandoned the fragment and judged there was no issue with leaving the fragment free, and a stent was unable to be placed in the om due to the size of the vessel.The procedure was completed with balloon angioplasty and stent placement at the site of the target lesion.The patient condition was good following the procedure.

• 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: sarah hicks ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 9318017
• MDR Text Key: 166938522
• Report Number: 3004742232-2019-00295
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491141
• UDI-Public: (01)10850000491141(17)210531(10)278413
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2019

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: 05/31/2021
• Device Model Number: GWC-12325LG-FT
• Device Lot Number: 278413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2019
• 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; Required Intervention
• Patient Age: 76 YR