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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE

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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Model Number PRD-SC30-MICRO
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation of Vessels (2135)
Event Date 06/07/2022
Event Type  Injury  
Event Description
During treatment in the distal anterior tibial artery and dorsalis pedis arteries, the stealth 360 peripheral orbital atherectomy device (oad) stalled while in the mid dorsalis pedis artery. The patient experiences restless leg syndrome and when intravascular ultrasound was employed, the vessel spasmed. When the oad was removed, a medial and inferior perforation of the dorsalis pedis artery was observed. Angioplasty was performed and left in place for 2 minutes to tamponade the vessel. Final angioplasty revealed a perforation was still present. The procedure was completed and, compression dressing was placed on access site on foot.
 
Manufacturer Narrative
The oad was received at csi for analysis. Review of the oad's data log, confirmed the reported stall. The root cause of the stall events was not determined. 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 diamondback 360® peripheral orbital atherectomy system instructions for use manual states that perforation and vessel spasm are potential adverse events that may occur and/or require intervention with use of the system. Csi id: (b)(4).
 
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Brand NameDIAMONDBACK 360 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
kim mcclure
1225 old hwy 8 nw
st. paul, MN 55112
6519006741
MDR Report Key14950106
MDR Text Key295472270
Report Number3004742232-2022-00157
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 07/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPRD-SC30-MICRO
Device Catalogue Number7-10059-01
Device Lot Number393313-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2021
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: 07/07/2022 Patient Sequence Number: 1
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