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

Model Number GWC-12325LG-FLP

Device Problems Material Separation (1562); Unexpected Shutdown (4019)

Patient Problems Perforation of Vessels (2135); Foreign Body In Patient (2687)

Event Date 12/05/2018

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.It was reported to csi that the device was being retained by the hospital facility.If the device is returned to csi it will be analyzed and a supplemental report will be submitted when the device analysis is completed.Csi id# (b)(4).

Event Description

During a coronary atherectomy procedure using a csi diamondback orbital atherectomy device (oad), the tip of the viperwire guide wire became detached and a perforation occurred.The target lesion was 95% stenosed and located in the left anterior descending artery (lad).Prior to atherectomy, two balloon angioplasty inflations were performed.The oad was then inserted and one pass was performed on low speed.It was noted that the guide wire had moved out of position, and it was moved to a more distal location.The lesion was treated with the oad again on low speed, and during the pass the device stopped functioning and an unusual noise was heard.The device was removed from the patient and imaging was performed.A perforation was noted and the tip of the guide wire was noted to be detached and remaining in the vessel.The patient was transferred to the operating room and bypass surgery was performed to resolve the perforation and retrieve the wire fragment.It was reported to csi that the patient remained in intensive care in stable condition, and a follow up procedure was performed (b)(6) 2018.It was reported to csi that the patient was stable and recovering following the follow up 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: laramie otto ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 8199661
• MDR Text Key: 131508813
• Report Number: 3004742232-2018-00384
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 30852528005187
• UDI-Public: (01)30852528005187(17)200731(10)11042800
• 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: 12/27/2018

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: 07/31/2020
• Device Model Number: GWC-12325LG-FLP
• Device Lot Number: 11042800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2018
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 48