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

Model Number PRD-SC30-MICRO

Device Problem Mechanical Problem (1384)

Patient Problem Perforation of Vessels (2135)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

The reported oad was received for analysis.Adhered biological material was observed on the crown of the oad.Examination of the area of adhered material did not reveal any damage.The morphology and root cause of the biological material was unknown.No damage to the driveshaft or crown that could have contributed to the perforation was observed.A guide wire was passed through the area of adhered material with no resistance.The oad spun at all speeds and functioned as intended.The data logs of the oad showed that a motor stall occurred.At the conclusion of the device analysis, the reported event of a perforation was unable to be conclusively confirmed.The log report of an oad stall may have been related to the event of the oad slowing down, however, this was unable to be conclusively confirmed.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

During a procedure with a stealth peripheral orbital atherectomy device (oad), a perforation occurred.The 100% occluded, heavily calcified lesion was located along the entire length of the posterior tibial artery (pt) and was treated on medium speed with the oad.The oad started to lose power and perforation occurred.The perforation was treated with balloon tamponade, and the procedure was delayed by greater than thirty (30) minutes.Pain medications were administered to the patient, a blood pressure cuff was applied.The patient was stable following the procedure.

• Brand Name: STEALTH 360 PERIPHERAL 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: 9781622
• MDR Text Key: 181817303
• Report Number: 3004742232-2020-00061
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491264
• UDI-Public: (01)10850000491264(17)210831(10)287247
• 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: 03/03/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: 7-10059-01
• Device Lot Number: 287247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2019
• 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): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 77