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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED STEALTH 360 ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

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CARDIOVASCULAR SYSTEMS INCORPORATED STEALTH 360 ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Model Number PRD-SC30-200
Device Problems Loss of Power (1475); Sticking (1597); Device Operates Differently Than Expected (2913)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 05/01/2015
Event Type  Injury  
Event Description
It was reported that during a peripheral orbital atherectomy procedure, the patient experienced an abrupt closure of the profunda artery after treatment with a csi orbital atherectomy device (oad).Additionally, the device got stuck on the guidewire and turned off during the procedure.The target lesion consisted of soft plaque and was located in the superficial femoral artery (sfa).The physician performed several runs at low, medium and at high speed using the oad, but during the final run, the device got stuck on the guidewire and turned off.After multiple removal attempts, the device was successfully removed off the wire.Post-atherectomy angiography revealed that the profunda artery had shut down.The physician resolved the vessel shut down by placing a stent.The patient status remained stable throughout the procedure.Requests for additional information have been made, but none has yet been received.
 
Manufacturer Narrative
Device analysis.The oad was returned without the original guidewire.The initial visual and tactile examination of the handle assembly, saline sheath and driveshaft revealed a bend in the driveshaft.Additionally, the strain relief was dislodged from the nosecone assembly.Further examination of the handle assembly revealed that the nosecone securing clips were damaged and fractured as a result of impact damage.The saline sheath was also damaged in this area.A kink in the driveshaft was observed 14.3cm distal to the adaptor hypotube lap weld.The exact cause of the damage could not be determined.Further examination revealed that the crown and distal tip bushing remained intact and undamaged.No biological material was observed on the driveshaft or crown.The outside diameter (od) of the crown and crown location on the driveshaft were measured and met the drawing specifications.The driveshaft was cut just proximal to the damage to allow further testing.An in-house 0.014" test wire was loaded through the device without issue.When tested, the device spun at low, medium and at high speed with no abnormalities observed.The device was turned on and off numerous times with no issues observed.While performing functional testing the power cord, brake and control knob were manually manipulated to determine if there were any functional concerns with the components that would have contributed to the reported event.The device and components functioned as intended with no abnormalities observed.At the conclusion of the failure analysis investigation, the root cause of the vessel shut down could not be determined.The root cause of the device becoming stuck on the guidewire also could not be determined.It could not be determined whether or not the damage was a result of device manipulation during removal or a result of shipping and handling during return to csi.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.(b)(4).
 
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Brand Name
STEALTH 360 ORBITAL ATHERECTOMY SYSTEM
Type of Device
PERIPHERAL ATHERECTOMY DEVICE
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS INCORPORATED
1225 old highway 8 nw
saint paul MN 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS INCORPORATED
1225 old highway 8 nw
saint paul MN 55112
Manufacturer Contact
megan brandt
1225 old hwy 8 nw
saint paul, MN 55112
6512592805
MDR Report Key4801195
MDR Text Key5931009
Report Number3004742232-2015-00038
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date03/31/2018
Device Model NumberPRD-SC30-200
Device Catalogue NumberPRD-SC30-200
Device Lot Number123906
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/01/2015
Initial Date FDA Received05/28/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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