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

Model Number DBEC-125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of consciousness (2418)

Event Date 04/15/2022

Event Type  Injury  

Manufacturer Narrative

Return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.See medwatch report 3004742232-2022-00132 pertaining to the viperwire advance guide wire.Csi id: (b)(4).

Event Description

Intravascular ultrasound (ivus) imaging was planned pre atherectomy, but the ivus catheter could not be advanced to the lesion.A diamondback 360 coronary orbital atherectomy device (oad) was used for treatment of the lesion.Six low speed treatments were performed proximal to the calcified lesion in the left circumflex (lcx) artery.However, the oad could not be advanced into the lesion.Balloon angioplasty was unsuccessful.The glideassist function was activated to advance the oad, but the viperwire advance guide wire migrated proximally.Another physician repositioned the guide wire and the wire tip came in contact with the oad, resulting in a fractured guide wire.An attempt was made to remove the guide wire fragment.The physician then observed the patient had lost consciousness.The patient's condition became critical, and cardiopulmonary resuscitation was performed.The patient regained consciousness.Due to the patient's condition, the procedure was stopped.

Manufacturer Narrative

The oad was returned to csi for analysis.There was no damage or abnormalities with the device that would have contributed to the reported complaints.The crown diameter was measured and is within specification.When tested the device functioned as intended.The device history record for this oad 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)(6).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• 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: kim mcclure ; 1225 old hwy 8 nw; st. paul, MN 55112 ; 6519006741
• MDR Report Key: 14631945
• MDR Text Key: 293548348
• Report Number: 3004742232-2022-00131
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005794
• UDI-Public: (01)10852528005794(17)230430(10)377314
• 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: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: DBEC-125
• Device Lot Number: 377314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2021
• 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 Sex: Male