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

Model Number	PRD-SC30-200
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Additional 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 prior to distribution.Csi id: (b)(4).
Event or Problem Description
A stealth peripheral orbital atherectomy device (oad) with a 2.0mm crown was used to treat heavily calcified lesions in the tibioperoneal trunk (tpt) and the proximal peroneal.Treatment began on low speed in the 3.0mm vessel and was increased to medium speed.The oad stopped spinning due to being stuck in the vessel.The control knob was manipulated to release the oad from the vessel and the crown spun freely, however it was then determined to be stuck on the viperwire guide wire.The oad was freed from the wire, however during removal from the patient it became stuck on the wire again.The wire and oad were removed together and tissue was visible on the crown and driveshaft.A non-csi wire was inserted but was unable to cross the tpt and peroneal.Imaging was performed and revealed a perforation in the proximal peroneal where the oad had become stuck.Tibial access was gained and a wire was inserted into the posterior tibial artery.Balloon angioplasty was performed in the diseased tibial regions and a stent was placed in the tpt and pt, jailing the peroneal, which greatly reduced the perforation extravasation.A non-flow limiting dissection was then noted near the area of oad treatment and was resolved with additional stent placement.Minimal extravasation remained at the conclusion of the procedure, which per the physician would resolve with cessation of heparin.The end result of the procedure was good and the patient was discharged the same day.
Additional 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 prior to distribution.Csi id: (b)(4).
Event or Problem Description
A stealth peripheral orbital atherectomy device (oad) with a 2.0mm crown was used to treat heavily calcified lesions in the tibioperoneal trunk (tpt) and the proximal peroneal.Treatment began on low speed in the 3.0mm vessel and was increased to medium speed.The oad stopped spinning due to being stuck in the vessel.The control knob was manipulated to release the oad from the vessel and the crown spun freely, however it was then determined to be stuck on the viperwire guide wire.The oad was freed from the wire, however during removal from the patient it became stuck on the wire again.The wire and oad were removed together and tissue was visible on the crown and driveshaft.A non-csi wire was inserted but was unable to cross the tpt and peroneal.Imaging was performed and revealed a perforation in the proximal peroneal where the oad had become stuck.Tibial access was gained and a wire was inserted into the posterior tibial artery.Balloon angioplasty was performed in the diseased tibial regions and a stent was placed in the tpt and pt, jailing the peroneal, which greatly reduced the perforation extravasation.A non-flow limiting dissection was then noted near the area of oad treatment and was resolved with additional stent placement.Minimal extravasation remained at the conclusion of the procedure, which per the physician would resolve with cessation of heparin.The end result of the procedure was good and the patient was discharged the same day.

• Brand Name: STEALTH PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; st. paul, mn, MN 55112 ; 6512591600
• MDR Report Key: 12970588
• Report Number: 3004742232-2021-00416
• Device Sequence Number: 4144284
• Product Code: MCW
• UDI-Device Identifier: 10850000491295
• UDI-Public: (01)10850000491295(17)230331(10)375009-1
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2021

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: 03/31/2023
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 7-10059-04
• Device Lot Number: 375009-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: Black Or African American