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U.S. Department of Health and Human Services

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

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CARDIOVASCULAR SYSTEMS, INC. STEALTH PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE, Back to Search Results
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.
 
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Brand NameSTEALTH PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL 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 Key9232968
MDR Text Key201687579
Report Number3004742232-2019-00274
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Model NumberPRD-SC30-MICRO
Device Catalogue Number7-10059-01
Device Lot Number286393
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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