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

Model Number	PRD-SC30-150
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad was received at csi for analysis with the guide wire engaged in the device.Visual examination confirmed the driveshaft crown area had been cut, and revealed adhered stent material on the distal driveshaft crown and tip bushing section.There was no damage observed on the crown that would have contributed to the adhesion of the stent material.The adhered stent material was an indication that the oad had spun in a previously placed stent, and had become stuck in the vessel, within the stent.The guide wire was confirmed to have been cut, and was removed from the oad without issue.There was no other damage observed with the guide wire.When tested, the oad spun on all speeds and all leds illuminated as expected.The oad functioned as intended.At the conclusion of the device analysis investigation, the reported event was confirmed to be due to user error due to spinning the oad within a previously placed stent.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.(b)(4).
Event or Problem Description
After two treatment passes, the stealth orbital atherectomy device (oad) and viperwire guide wire became stuck in the anterior tibial artery.The oad and guide wire were cut to facilitate removal attempts.A non-csi 8fr sheath was inserted into the patient to remove the crown and guide wire, but was unsuccessful.The sheath was exchanged for a non-csi 10f sheath, and the crown and guide wire were removed from the patient.There were no patient complications and the patient was discharged the same day.Analysis of the device confirmed the presence of adhered stent material on the crown of the oad.It was unknown that a previously placed stent was present in the patient, and that the device had inadvertently operated within the stent.

• 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
• MDR Report Key: 9771979
• Report Number: 3004742232-2020-00059
• Device Sequence Number: 2770114
• Product Code: MCW
• UDI-Device Identifier: 10852528005046
• UDI-Public: (01)10852528005046(17)221231(10)302506
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• 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): 02/28/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PRD-SC30-150
• Device Catalogue Number: 70056-04
• Device Lot Number: 302506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/28/2020
• 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: 73 YR