CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE
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Model Number DBP-200MAX145 |
Device Problem
Unintended System Motion (1430)
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Patient Problems
Perforation of Vessels (2135); Vascular Dissection (3160); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/19/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 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.Csi id: (b)(4).
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Event Description
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A diamondback 360 peripheral orbital atherectomy device was advanced through a 6fr sheath into the anterior tibial artery (at) to perform treatment in the distal superficial femoral artery (sfa) and popliteal artery.At the at, the oad began to jump forward.The oad was removed.Balloon angioplasty was performed in entire length of the at with a 3.5 mm balloon.The physician again advanced the oad and treated the lesion in the distal sfa/popliteal artery on low speed for 25 seconds, and then on medium speed for 25 seconds with rests in between.Imaging was performed and a 6x100 mm balloon was advanced.Imaging was performed and a perforation was revealed in the at.Using the 3.5 mm balloon, dilation was performed in the at.Imaging revealed three vessel runoff.The patient was removed from the operating room (or) to recover.A couple hours later, the patient complaint of a pain and the calf muscle being hard.The patient was returned to the or, and imaging performed that revealed no flow.The physician obtained access via the femoral artery and observed a dissection flap.An unsuccessful attempt was made to place stents as the vessel was unable to be opened.The patient was then sent to the hospital for ekos acoustic pulse thrombolysis.
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