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

Model Number	DBP-125SOLID145
Medical Device Problem Codes	Entrapment of Device (1212); Unintended System Motion (1430)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported orbital atherectomy device (oad) was returned with the guide wire engaged and stuck in the device.Detailed analysis revealed adhered and embedded biological material on the driveshaft and on the guide wire which prevented removal of the guide wire from the device.There was no damage observed with the device or the guide wire that would have contributed to the reported event.When tested the device spun during all three speeds and functioned with no abnormalities observed.The morphology of the biological material is not known and the exact root cause of accumulating tissue remains unknown.Examination in the areas of the adhered tissue did not reveal any damage that would have contributed to the accumulation.At the conclusion of the device analysis investigation, the reported event of the oad becoming stuck on the guide wire was confirmed.However, the root cause of the device becoming stuck on the guide wire, crown jumping, and dissection could not be conclusively determined.(b)(4).
Event or Problem Description
During an atherectomy procedure using a csi peripheral orbital atherectomy device (oad), a dissection occurred.The target lesion was in the tibial-peroneal trunk (tpt) artery.The crown of the device was noted to jump back at the completion of the passes through the lesion.Upon removal of the device, it was noted to be stuck on the guide wire.The device and the wire were removed together and a dissection was noted to have occurred.The dissection was treated with the placement of a stent.The patient was reported to be in stable condition after the procedure and no further patient complications have been reported as a result of this 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: 7487836
• Report Number: 3004742232-2018-00123
• Device Sequence Number: 2052830
• Product Code: MCW
• UDI-Device Identifier: 10852528005244
• UDI-Public: (01)10852528005244(17)200131(10)213398
• 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): 05/04/2018

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: Physician
• Device Expiration Date: 01/31/2020
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: DBP-125SOLID145
• Device Lot Number: 213398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 05/04/2018
• 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: 75 YR
• Patient Weight: 68