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

Model Number	DBP-125MICRO145
Medical Device Problem Codes	Off-Label Use (1494); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/31/2019
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 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.The diamondback 360® peripheral orbital atherectomy system instructions for use states that use of the oas is contraindicated when the target lesion is within a stent.Csi id# (b)(4).
Event or Problem Description
During a procedure with a coronary diamondback orbital atherectomy device (oad), the oad was operated in a stent and the stent fractured in the patient.The oad was operated in the peroneal artery and balloon angioplasty was performed with no issues observed.The balloon was re-positioned towards the arterial tibial artery (at) and was unable to cross the proximal side of the at.Intravascular ultrasound (ivus) was performed and the oad was operated for one treatment until it powered down and was removed, and it was noted that it had been operated in a preexisting stent.The stent had fractured into three fragments.Attempts with balloon angioplasty and a non-csi support catheter were made to retrieve the stent fragments, but were unsuccessful and the case was aborted.The patient was stable and had better flow post procedure.It is planned for the patient to have an additional procedure.The physician had placed the stent in a previous procedure, but due to the fact that it was a coronary stent in the peripheral vasculature, it was not clearly visible during imaging.

• 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: 8935487
• Report Number: 3004742232-2019-00224
• Device Sequence Number: 16601465
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)210531(10)271543
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

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: 05/31/2021
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 271543
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/27/2019
• 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: Other