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

Model Number	PRD-SC30-200
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).
Event or Problem Description
During treatment of a calcified lesion in the tibioperoneal (tp) trunk with a csi stealth orbital atherectomy device (oad), the device was inadvertently operated inside of a previously placed stent and became stuck.It was unknown that a previously placed stent was present in this location.Per the physician, the arch was highly tortuous and the crown used may have been too large for the vessel.The oad, guide wire and stent were removed by pulling on the guide wire, and all devices were removed from the patient.The lesion was re-accessed and the area was treated with balloon angioplasty and stent placement.The patient was stable and discharged the day of the procedure.
Additional Manufacturer Narrative
The reported oad was received for analysis with the viperwire guide wire used during the procedure.The tip bushing of the oad and the end of the guide wire were observed to have been destructively cut.The end of the guide wire was not returned.Stent material was observed to be attached to the oad driveshaft proximal to the crown.Scanning electron microscopy was performed and identified destructively cut filars on both sides of the crown and on the proximal driveshaft section.At the conclusion of the device analysis investigation, the reported event was confirmed to be due to user error due to spinning the oad inside of a previously placed stent.The instructions for use for the reported device state that use of the oas is contraindicated if the target lesion is within a bypass graft or 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 prior to distribution.Csi id: (b)(4).

• Brand Name: PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul MN 55112
• MDR Report Key: 8721742
• Report Number: 3004742232-2019-00160
• Device Sequence Number: 2004025
• Product Code: MCW
• UDI-Device Identifier: 10852528005053
• UDI-Public: (01)10852528005053(17)220331(10)264626
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110389
• 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,Followup
• Report Date (Section B): 06/21/2019

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: 03/31/2022
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 70056-06
• Device Lot Number: 264626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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: Required Intervention