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

Model Number PRD-SC30-200

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

The reported oad was received for analysis. The oad driveshaft near the lap weld was overloaded. It was possible the overloaded driveshaft may have been a contributing factor in the reported event, however, the root cause of the damage was unable to be determined. Driveshaft overloading is an indication that the spinning driveshaft met sudden resistance bringing it to a stall condition. No other damage on the driveshaft or handle assembly was observed. Blood was observed within the saline sheath. The fluid accumulation is not considered a contributing factor to the reported event. A guide wire was unable to pass through the overloaded area of the driveshaft. The oad was tested, spun on all speeds and functioned as intended. The control knob was traversed, and the crown moved at a 1:1 ratio with the control knob. The oad was turned on and off numerous times without any issue or popping noise observed. At the conclusion of the device analysis, the reported event of a popping noise and the control knob and crown moving independently was not able 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. Csi id# (b)(4).

Event Description

A stealth orbital atherectomy device (oad) was selected for treatment of a heavily stenosed lesion in the common femoral artery (cfa) via brachial access. The oad was positioned using significant force, and as the oad engaged the lesion, a popping sound was heard. The oad was turned off, and it was noted that the control knob and crown were not moving at a 1:1 ratio. The oad and guide wire were removed, and the crown was observed to move independently of the control knob. The lesion was difficult to rewire, and the procedure was delayed by greater than 30 minutes. The procedure was completed with balloon angioplasty, and no patient adverse events were reported.

• 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 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: sarah hicks ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 11046535
• MDR Text Key: 228440371
• Report Number: 3004742232-2020-00415
• Device Sequence Number: 1
• Product Code: MCW
• 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

• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 70056-06
• Device Lot Number: 306429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial