MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE ADVANCE); CORONARY ATHERECTOMY DEVICE (GUIDE WIRE)

Model Number GWC-12325LG-FT

Device Problem Material Separation (1562)

Patient Problems Loss of consciousness (2418); Foreign Body In Patient (2687)

Event Date 04/15/2022

Event Type  Injury  

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

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 3004742232-2022-00131 pertaining to the diamondback 360 coronary orbital atherectomy device.Csi id: (b)(4).

Manufacturer Narrative

The viperwire advance guide wire was returned to csi for analysis.Visual examination confirmed the reported fracture.Sem analysis showed evidence of torsion on the fracture faces and rotational wear on the surface of the proximal solder bond.This can occur from spinning the driveshaft too close to the spring tip.The root cause of the wire fracture is considered to be use not consistent with ifu.The diamondback 360® coronary orbital atherectomy system instructions for use manual cautions, "maintain at least 5 mm between the proximal end of the viperwire guide wire spring tip and the oad drive shaft tip to prevent contact of the drive shaft tip with the guide wire spring tip.Further advance the viperwire guide wire, as necessary, to maintain the 5 mm minimum distance." the material inspection report for this guidewire 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)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE ADVANCE)
• Type of Device: CORONARY ATHERECTOMY DEVICE (GUIDE WIRE)
• 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: 14632252
• MDR Text Key: 293548669
• Report Number: 3004742232-2022-00132
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491141
• UDI-Public: (01)10850000491141(17)230531(10)382523-1
• 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: 07/07/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: GWC-12325LG-FT
• Device Lot Number: 382523-1
• 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: 05/10/2022
• Supplement Dates FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2022
• 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