• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CARDIOVASCULAR SYSTEMS, INC. STEALTH ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTEALTH ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL 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 Key10270165
MDR Text Key198751461
Report Number3004742232-2020-00201
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190634
Number of Events Reported1
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 Received07/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRD-SC30-200
Device Catalogue Number70056-06
Device Lot Number326222
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-