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

Model Number	PRD-SC30-200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); No Code Available (3191)
Date of Event	07/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad was received for analysis.No damage was visually observed.A guide was passed through the oad handle and driveshaft with no resistance.When tested, the oad spun on all speeds with all leds lit as expected, and functioned as intended.At the conclusion of the device analysis, the reported events of a perforation, unusual noise, and blinking led light were unable to be conclusively confirmed.As the perforation occurred following oas and balloon angioplasty, it was unable to be determined if the blinking led lights and unusual noise were related to the perforation.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
A stealth peripheral orbital atherectomy device (oad) was selected for treatment in the superficial femoral artery (sfa) via popliteal access.The lesion was wired, and intravascular ultrasound was used.The guide wire was clearly subintimal and not in the true lumen.The physician decided to move forward despite the placement of the wire in the subintimal space.He treated the lesion with oa on low speed, and the patient complained of discomfort.High speed was selected, and the oad made a loud sound that had not been heard on low or medium speed.One of the leds on the oad handle blinked at the same time as the loud noise.The oad was removed, and balloon angioplasty was performed.Imaging was performed after angioplasty, and a perforation and vessel injury were observed.It was noted the oad contributed to the perforation and vessel injury.Two covered stents were placed to treat the perforation.The patient was transferred to the hospital and had a fasciotomy to resolve remaining pressure at the injury site on (b)(6) 2020.As of (b)(6) 2020, the patient was stable and hospitalized.

• Brand Name: STEALTH 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: 10460942
• Report Number: 3004742232-2020-00261
• Device Sequence Number: 2808853
• Product Code: MCW
• UDI-Device Identifier: 10852528005053
• UDI-Public: (01)10852528005053(17)220131(10)255216
• 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): 08/27/2020

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 Expiration Date: 01/31/2022
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 70056-06
• Device Lot Number: 255216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/27/2020
• 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: Hospitalization; Required Intervention