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

Model Number DBP-EX-200SOL145

Device Problem Off-Label Use (1494)

Patient Problem Vascular Dissection (3160)

Event Date 04/12/2022

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the reported device was not returned for analysis.The device history record for the reported oad could not be reviewed as the lot number was not provided.Based on the information received, the cause of the reported event could not be conclusively determined.In the opinion of staff at the facility, the cause of the event was use of the device for longer than advised and without rest periods in the instructions for use manual, which led to the device becoming entrapped on the wire.Instruction has been provided to the physician regarding the need for rest periods between treatments.Csi id: (b)(4).

Event Description

While performing a treatment with a diamondback 360 exchangeable orbital atherectomy device (oad), the viperwire advance guide wire became entrapped on the driveshaft.When the driveshaft became entrapped on the wire, the filter began spinning.Treatment was stopped and did not resume.Unsuccessful attempts were made to remove the oad from the wire.All components were then removed from the patient.Multiple dissections were revealed under fluoroscopy.The vessel was rewired and balloon angioplasty was performed to complete the procedure.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL 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: 14462708
• MDR Text Key: 292751130
• Report Number: 3004742232-2022-00122
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBP-EX-200SOL145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 80 YR
• Patient Weight: 136 KG