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

Model Number	DBP-EX-200SOL145
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A diamondback 360 exchangeable orbital atherectomy device (oad) was used to treat a heavily calcified left external iliac artery.Two treatments were performed on low speed, two on medium speed, and one on high speed.The oad was then advanced to the common femoral artery, superficial femoral artery, and tibial artery.The physician elected to not exchange the 11cm guide sheath for a longer sheath.Three treatments were performed on low speed and one treatment on medium speed.During removal, the oad experienced difficulty passing the bifurcation.Glideassist was activated, however, the device turned off.Two further attempts were made to activate glideassist, however, the issue persisted.An attempt to advance the oad over the were was performed, however the crown appeared to be stuck to the later side of the right iliac artery and aorta junction due to suspected calcium.An unsuccessful treatment on low speed was attempted.The oad became stuck in the vessel.When changing guide wires, the viperwire advance guide wire was difficult to remove.Once removal was successful, a kink was observed.Another attempt to remove the oad was made, however, unsuccessful.The saline sheath and drive shaft were cut from the nose cone and a 6fr guide sheath was put over the drive shaft and through the sheath to the crown.The crown could not go through the 6fr guide sheath.A 8fr guide sheath was placed over the saline sheath and drive shaft component.The oad was successfully removed.Visual examination confirmed damage of the driveshaft.An angiogram was performed and there was a slight tinge that indicated a minor dissection may have occurred.As angiogram imaging was not taken during treatment, it was unable to be determined if a minor dissection occurred or if it was calcium.Balloon angioplasty and stent placement were performed to complete the procedure.The patient was stable.
Additional Manufacturer Narrative
The oad was returned to csi with fractured driveshaft filars at the proximal edge of the crown.The driveshaft was not fully separated.Scanning electron microscopic analysis of the filars revealed evidence of fatigue.This is indicative that the driveshaft was spun in a high stress environment.Diagnostic analysis revealed stall events near the end of the procedure.The reported event of driveshaft damage and no power to handle were confirmed, however, the root cause could not be conclusively determined.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: 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: 15828256
• Report Number: 3004742232-2022-00288
• Device Sequence Number: 12301345
• Product Code: MCW
• UDI-Device Identifier: 10852528005848
• UDI-Public: (01)10852528005848(17)240731(10)442481
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: DBP-EX-200SOL145
• Device Catalogue Number: 7-10030-04
• Device Lot Number: 442481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White