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

Model Number DBP-EX-200MAX145

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

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

Event Date 07/12/2023

Event Type  Injury  

Manufacturer Narrative

H6 health effect - clinical code 4581: slow/no flow.H6 investigation conclusion code 22: the diamondback 360® exchangeable peripheral orbital atherectomy system instructions for user manual states that embolism and slow/no flow or reflow phenomenon is a potential adverse event that may occur and/or require intervention with use of the system.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.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.Csi id: (b)(4).

Event Description

Multiple treatments were performed in the superficial femoral artery (sfa) with the diamondback 360 exchangeable peripheral orbital atherectomy device (oad).Post treatment, angiographic imaging confirmed no flow below the knee.A stent was placed and then an aspiration catheter and tissue plasminogen activator (tpa) were used to treat the plaque embolism.Flow was restored in the posterior (pt) and a part of the peroneal arteries but not in the anterior tibial (at).The following day, the patient was confirmed to have palpable pulses.The patient was stable and will continue to be monitored.

• 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: poonoy chanthavongsa ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 17487660
• MDR Text Key: 320675009
• Report Number: 3004742232-2023-00193
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850026568476
• UDI-Public: (01)10850026568476(17)240831(10)447419
• 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: 08/09/2023

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 Model Number: DBP-EX-200MAX145
• Device Catalogue Number: 7-10030-13
• Device Lot Number: 447419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White