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

Model Number DBP-150SOLID145

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

Patient Problems Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/04/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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)(4).

Event Description

A diamondback 360 peripheral orbital atherectomy device (oad) was used for treatment of three focal chronic total occlusions in the femoral and popiteal arteries.Each lesion was about 1cm in length.The oad was used on low, medium, and high speed one lesion at a time from proximal to distal.Imaging thereafter showed no flow at all below the knee, whereas flow had been present prior.The patient was sent to surgery for a thrombectomy and bypass.The patient was well following the procedure.In the opinion of the physician, no flow was caused by distal embolization from oa.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE
• 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: sadie martin ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 13965285
• MDR Text Key: 288284712
• Report Number: 3004742232-2022-00076
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491226
• UDI-Public: (01)10850000491226(17)230430(10)376319-1
• 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: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• 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: DBP-150SOLID145
• Device Catalogue Number: 7-10057-06
• Device Lot Number: 376319-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• 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: Female