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

Model Number DBP-200SOLID145

Device Problem Unexpected Shutdown (4019)

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

Event Date 09/30/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).

Event Description

Pre-procedure image quality was poor.Intravascular lithotripsy was performed in the superficial femoral artery (sfa), then multiple short treatments on low, medium, and high speed were performed using a diamondback 360 peripheral orbital atherectomy device (oad) in the common femoral artery and the sfa.During the last treatment, the oad had stopped turning on.The oad was powered on again, leds blinked and the oad again turned off.Following the last treatment, no flow was observed.Cardene and nitroglycerine were administered and flow improved but remained slow, and embolization occurred in the distal posterior tibial.Angioplasty balloons were used to improve flow, however the issue persisted.The patient was hospitalized with a heparin drip.Flow was restored.The patient was brought back to check the area with doppler, and the foot was warm with observable pulses.As the patient experienced poor kidney health, imaging was kept to a minimum throughout the procedure.In the opinion of the physician, multiple treatments led to the embolization.Future treatment was being planned.

Manufacturer Narrative

The oad was returned to csi for evaluation.Review of the diagnostic analysis identified a motor hardware fault event.Diagnostic analysis confirmed a stall event.The root cause of the 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).

• 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: 15772845
• MDR Text Key: 303544998
• Report Number: 3004742232-2022-00255
• 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,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: 7-10057-04
• Device Lot Number: 336828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2020
• 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 Age: 82 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Race: White