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

Model Number PRD-SC30-MICRO

Device Problem Entrapment of Device (1212)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

The oad and guide wire were received for analysis.The oad driveshaft was cut and was stretched and deformed at the cut.The distal driveshaft, including the crown, was not returned.No additional damage was observed on the oad.The device data logs revealed numerous motor stall that occurred.The stall events did not recur during device analysis.The oad was tested, spun on all speeds, and functioned as intended.At the conclusion of the device analysis, the report of the oad becoming stuck in the vessel was unable to be conclusively confirmed.It was possible that the stalls that occurred in the device log could be attributed to the device being stuck in the vessel; however, the root cause of the stall events could not be 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.3004742232-2020-00225 is related to the guide wire used during this procedure.Csi id# (b)(4).

Event Description

A stealth peripheral orbital atherectomy device (oad) was selected for treatment of a lesion in the proximal anterior tibial (at) artery.The lesion was long and 100% occluded.The oad became stuck and attempts were performed to loosen it, including cutting the oad.However, the attempts were unsuccessful.The patient was transferred to surgery to remove the oad.All portions of the oad were removed during surgery, and as of (b)(6) 2020, the patient status post-surgery was fine.

• 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: 10353127
• MDR Text Key: 207915823
• Report Number: 3004742232-2020-00224
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491264
• UDI-Public: (01)10850000491264(17)220331(10)317776
• 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: 07/31/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: 7-10059-01
• Device Lot Number: 317776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2020
• 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: 86