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

Model Number PRD-SC30-200

Device Problem Material Integrity Problem (2978)

Patient Problem Missing Value Reason (3192)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

Device analysis conclusion: the oad was received at csi for analysis. Visual examination revealed a bend in the driveshaft near the proximal edge of the crown and fractured driveshaft filars within the saline sheath. One of the filars was protruding from the saline sheath. The fractured section was sent for scanning electron microscopy analysis, which revealed the driveshaft had fractured due to excessive torsional forces and fatigue. Although the root cause of the driveshaft damage and fractured filars is not conclusive, it is likely the result of localized, elevated stress levels applied to the driveshaft while spinning. The shaft damage prevented the oad from functioning as intended during functional testing. As the original guidewire was not returned for analysis, it could not be determined if it was damaged or contributed to the fracture. The device history record for this device lot number has been reviewed. No issues or discrepancies were noted during this review that would have contributed to the reported event and the device met material, assembly, and quality control requirements prior to distribution. (b)(4).

Event Description

The stealth orbital atherectomy device (oad) was being analyzed for an issue that was not considered reportable. However, during failure analysis, a fracture was identified.

• Brand Name: STEALTH ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul, mn
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul, mn
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, mn
• MDR Report Key: 10270165
• MDR Text Key: 198751461
• Report Number: 3004742232-2020-00201
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/14/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/14/2020
• 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: 326222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial