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

Model Number	DBP-EX-125MIC145
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Review of imaging following the procedure revealed that the vessel spasm likely occurred due to the oad being in the tight artery.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.(b)(4).Csi id: (b)(4).
Event or Problem Description
The diamondback exchangeable orbital atherectomy system (oad) was selected for treatment of a patient who had pre-existing no flow in the anterior tibial artery and was experiencing pain.The oad was operated in the at artery on low and medium speed without issue and then advanced to the mid at, however the device sounded as though it were wrapped around tissue.The control knob was locked and the crown was retracted, however the crown would not move as it was stuck in the vessel and the patient experienced pain.Nitroglycerin and verapamil were administered to loosen the vessel, due to a spasm that had occurred, however this was unsuccessful.Due to the size of the sheath, balloons and guide catheters could not be advanced over the crown.The oad was manually tugged, but the crown remained stuck.Glideassist mode was activated and the crown moved a few inches, but then stopped and the patient experienced additional pain.During attempts to remove the oad, the oad became stretched.The driveshaft was cut and removed from the saline sheath.The catheter was still in place with the crown in the proximal at.A catheter was advanced and placed by the crown.Pulling and manipulation of the crown were performed, and the patient experienced hypotension and pain.The crown remained stuck.The catheter was pulled harder, and was removed, however the crown detached and remained in vivo.An angiogram revealed the at was shut down, however this was likely a pre-existing condition prior to the procedure.Balloon angioplasty was performed to the posterior tibial artery.Following the procedure the patient had pain unrelated to the oad and a week following the procedure the patient was doing well.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 13533855
• Report Number: 3004742232-2022-00039
• Device Sequence Number: 12049087
• Product Code: MCW
• UDI-Device Identifier: 10852528005817
• UDI-Public: (01)10852528005817(17)231130(10)411330
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/15/2022

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 Model Number: DBP-EX-125MIC145
• Device Catalogue Number: 7-10030-01
• Device Lot Number: 411330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White