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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-SC30-200
Device Problem Mechanical Problem (1384)
Patient Problems Vascular Dissection (3160); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/17/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Device analysis conclusion: the oad and guidewire were received at csi for analysis. The guidewire was not engaged in the device. There was a slight bend in the core shaft of the guidewire. The damage likely occurred during shipping. The damage was not considered a contributing factor in the reported complaint. There was no other visible damage, and there was no damage observed with the driveshaft or handle assembly that would have contributed to slow flow or the reported dissection. The device data log was reviewed, and a bog event was observed. A bog event indicates a drop in device speed. The cause of the bog event could not be determined through analysis; the oad functioned as intended during testing. 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. 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 peripheral orbital atherectomy device (oad) was used for treatment of a 90% stenosed lesion in the superficial femoral artery (sfa). Multiple treatment passes were performed on all speeds. During pullback to the resting position, the oad slowed and stalled. Some resistance was encountered during removal of the oad. This was attributed to the 2mm crown size and bifurcation characteristics. Angiography then showed flow was sluggish, and there was no flow through the treated segment. Angioplasty was applied, but a significant dissection was noted. A stent was deployed over the treatment area, and flow was brisk thereafter.
 
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Brand NameSTEALTH PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL ATHERECTOMY DEVICE
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul MN 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul MN 55112
Manufacturer Contact
morgan hill
1225 old hwy 8 nw
st. paul, MN 55112
MDR Report Key13022648
MDR Text Key285550205
Report Number3004742232-2021-00421
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPRD-SC30-200
Device Catalogue Number7-10059-04
Device Lot Number393125-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/16/2021 Patient Sequence Number: 1
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