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

Model Number DBP-125MICRO145

Device Problems Off-Label Use (1494); Device Damaged by Another Device (2915)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/31/2019

Event Type  Injury  

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 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
• Type of Device: 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: 8935487
• MDR Text Key: 156404765
• Report Number: 3004742232-2019-00224
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)210531(10)271543
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2019
• 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): Other