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

Model Number	DBP-150SOLID145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/08/2020
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.The diamondback peripheral orbital atherectomy system instructions for use warns that a perforation is a potential adverse event that may occur and/or require intervention as a result of the use of this device.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).
Event or Problem Description
A diamondback peripheral orbital atherectomy device (oad) was selected to treat a heavily calcified, 90% stenosed lesion in the left posterior tibial artery.The vessel was 3.0 mm in diameter.During treatment, the patient inadvertently bent their knee and caused the crown to move laterally.The oad stalled and was removed from the patient, and imaging identified a vessel perforation.Balloon angioplasty and stent placement were performed to the perforation site and a blood pressure cuff was placed on the patient's leg to tamponade the perforation.The patient was stable following the procedure and the patient was reported to be doing well.Per the opinion of the physician, the patient's movement was the primary factor in the cause of the perforation event.

• 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
• MDR Report Key: 11059236
• Report Number: 3004742232-2020-00420
• Device Sequence Number: 2636184
• Product Code: MCW
• UDI-Device Identifier: 10850000491196
• UDI-Public: (01)10850000491196(17)220731(10)336780
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: DBP-150SOLID145
• Device Catalogue Number: 7-10057-03
• Device Lot Number: 336780
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 82