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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 VPR-GW-14
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/03/2020
Event Type  Injury  
Manufacturer Narrative
The guide wire was received at csi for analysis. Visual examination revealed the guide wire was fractured, and that the spring tip was intact with no damage observed. Scanning electron microscopy analysis revealed evidence of fatigue and a large crack down the middle of the guide wire, which was consistent with a fracture due to use of the wire in an unusually elevated stress environment. At the conclusion of the device analysis investigation, the report that the guide wire had fractured was confirmed, however the exact root cause of the fractures could not be determined. The material inspection report for this guide wire 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).
 
Event Description
Orbital atherectomy treatment was successfully performed in the superficial femoral artery, and the peripheral orbital atherectomy device was removed from the patient. Multiple balloons were inserted over the viperwire guide wire and balloon angioplasty was performed. The balloons and wire were removed from the patient. An angiogram was performed and revealed that part of the guide wire had fractured and remained in the sheath. The fragment was retrieved from the sheath with a snare device. The patient condition following the procedure was described as "fine. ".
 
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Brand NameDIAMONDBACK 360 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
brittany leider
1225 old highway 8 nw
saint paul, MN 55112
6512591600
MDR Report Key11064551
MDR Text Key223376150
Report Number3004742232-2020-00417
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
Report Date 12/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Model NumberVPR-GW-14
Device Catalogue Number72023-01
Device Lot Number328047
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/27/2020
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: 12/23/2020 Patient Sequence Number: 1
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