MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number PRD-SC30-150

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Thrombus (2101)

Event Date 07/09/2015

Event Type  Injury  

Manufacturer Narrative

The device was discarded by the facility; therefore, an analysis of the actual complaint device is not possible.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.(b)(4).Discarded by facility.

Event Description

It was reported that during a peripheral orbital atherectomy procedure, the patient experienced a thrombus event after use with a csi orbital atherectomy device (oad).There were multiple lesions located in the superficial femoral artery (sfa), popliteal and posterior tibial (pt) artery.The physician performed multiple runs using a csi oad to treat the lesions.Atherectomy was followed-up with balloon angioplasty and stent placement.Follow-up angiography revealed a shifting of thrombus that extended into the tibioperoneal trunk (tpt), as well as the pt and peroneal arteries.The physician resolved the thrombus shift via additional angioplasty and thrombectomy.The patient status remained stable throughout the procedure.

• Brand Name: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: megan brandt ; 1225 old hwy 8 nw; saint paul, MN 55112 ; 6512592805
• MDR Report Key: 4988101
• MDR Text Key: 22435018
• Report Number: 3004742232-2015-00054
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study,user facility
• Reporter Occupation: Physician
• Report Date: 08/05/2015

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: Physician
• Device Expiration Date: 12/31/2017
• Device Model Number: PRD-SC30-150
• Device Catalogue Number: PRD-SC30-150
• Device Lot Number: 117512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2014
• 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 Age: 74 YR
• Patient Weight: 88