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

Model Number GWC-12325LG-FLP

Device Problems Unintended System Motion (1430); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/30/2019

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.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.(b)(4).

Event Description

The tip of the viperwire guide wire fractured during treatment of an 80% stenosed lesion in the left anterior descending artery.The fragment was abandoned in vivo, and the procedure was completed with an otherwise good result.During treatment, the guide catheter was not stationary.The physician and field staff thought the guide catheter movement may have pulled the viperwire, and the spring tip may have gotten too close to the atherectomy device.

• Brand Name: DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 9505587
• MDR Text Key: 172293388
• Report Number: 3004742232-2019-00336
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 30852528005187
• UDI-Public: (01)30852528005187(17)210331(10)11144567
• 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: 12/20/2019

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: 03/31/2021
• Device Model Number: GWC-12325LG-FLP
• Device Lot Number: 11144567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2019
• Initial Date FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2019
• 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