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

Model Number PRD-SC30-200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); No Code Available (3191)

Event Date 07/24/2020

Event Type  Injury  

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 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
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer Contact: sarah hicks ; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 10460942
• MDR Text Key: 204586874
• Report Number: 3004742232-2020-00261
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005053
• UDI-Public: (01)10852528005053(17)220131(10)255216
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention