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

Model Number DBP-EX-200SOL145

Device Problem Mechanical Problem (1384)

Patient Problem Vascular Dissection (3160)

Event Date 08/31/2022

Event Type  Injury  

Manufacturer Narrative

The oad was returned to csi for analysis.Diagnostic review of the oad revealed several stall events.It is unknown if the stall events are related to the major dissection.The root cause of the stall events was unable to be determined.There is some adhered biological material accumulated on the driveshaft crown section, however, further examination did not reveal any damage or abnormalities that would have contributed to the material accumulation.Also, the crown and sheath diameters were measured and met specifications.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.When tested, the oad functioned as intended.The instructions for use warns to not continue treatment if the guide wire or oad becomes sub-intimal.Csi id: (b)(4).

Event Description

A diamondback 360 exchangeable orbital atherectomy device (oad) was used sub-intimal to treat a heavily calcified superficial femoral artery (sfa).When treatment was performed on medium speed and high speed, the oad stalled three times.No indicator lights were blinking while the device stalled.An angiogram was performed and revealed a severe dissection.The oad was removed.Balloon angioplasty and stent placement were performed to resolve the dissection.The patient was admitted to the hospital for overnight observation.The patient was stable and discharged.

• 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: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 15463325
• MDR Text Key: 300371686
• Report Number: 3004742232-2022-00227
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005848
• UDI-Public: (01)10852528005848(17)240430(10)430297
• 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: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DBP-EX-200SOL145
• Device Catalogue Number: 7-10030-04
• Device Lot Number: 430297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2022
• 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): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White