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

Model Number PRD-SC30-MICRO

Device Problems Contamination (1120); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).

Event Description

A coronary stealth orbital atherectomy device (oad) was used to successfully treat a lesion in the posterior tibial artery.A second, severely calcified lesion in the anterior tibial artery was then going to be treated with the oad via an antegrade approach.However, when attempting to pass the guide wire through the oad, the guide wire would not pass the crown of the driveshaft.It appeared there was something obstructing the distal opening of the driveshaft.The wire was unable to pass through the oad and treatment of the anterior tibial artery was aborted.It was noted that the control knob of the oad was in the correct placement for wire pass through.It was planned to bring the patient back at a later date to treat the anterior tibial artery lesion.It was noted there was no patient complications during the procedure.

Manufacturer Narrative

The reported device was received for analysis.A blockage of biological material was observed within the driveshaft crown and tip bushing area.Although the root cause of the accumulating material remains unknown, it is hypothesized that it occurred during treatment of the first lesion.When the device was removed from the patient in preparation for the second treatment, the time lapse may have allowed the material to solidify and prevent a guide wire from passing back through.The morphology and root cause of the biological material was unknown.The blockage prevented a guide wire from passing through the device.The area with the blockage was removed, and a guide wire passed through the rest of the driveshaft and handle with no resistance.The oad functioned on all speeds as intended with no abnormalities observed.At the conclusion of the device analysis, the reported event of the guide wire not passing through the device was 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.Results code: 4247 - suggested code is biological material present on device.Csi id# (b)(4).

• Brand Name: STEALTH PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE,
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 9232968
• MDR Text Key: 201687579
• Report Number: 3004742232-2019-00274
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491264
• UDI-Public: (01)10850000491264(17)210831(10)286393
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 286393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR