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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-FLEX14
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/30/2020
Event Type  Injury  
Manufacturer Narrative
The reported oad and a partial segment of the viperwire guide wire were received. The viperwire was fractured, and the fractured segment was lodged within the oad driveshaft. The proximal viperwire and distal spring tip were not returned. The guide wire fragment was removed from the oad with resistance. The fractured segment was damaged and deformed. Scanning electron microscopy (sem) of the oad tip bushing revealed radiopaque particles on the tip bushing. Sem of the viperwire fragment showed evidence of torsional forces. This damage is consistent with the spinning oad driveshaft making contact with the viperwire spring tip. When tested, the oad functioned as intended. At the conclusion of the device analysis, the reported event of a guide wire fracture was confirmed. The orbital atherectomy system instruction for use states, "when moving the crown advancer knob, make sure there is sufficient distance between the guide wire spring tip and the distal end of the shaft (10 cm minimum). If the distance between the shaft tip and the guide wire spring tip is insufficient, the shaft tip may damage the guide wire spring tip and result in dislodgement of the guide wire spring tip. Use contrast injections and fluoroscopy to monitor movement of the shaft tip in relation to the guide wire spring tip. " 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 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. Csi id# (b)(4).
 
Event Description
A diamondback peripheral orbital atherectomy device (oad) and viperwire guide wire were selected for treatment of a calcified lesion in the anterior tibial artery. The oad would not cross the lesion, and the guide wire retracted while the oad was in glideassist mode. An attempt was made to advance the viperwire, however, the viperwire retracted, and the spring tip fractured. The viperwire fragment remained in the patient. No snare attempts were performed, as the lesion was not opened, and no other device could cross. The at was not treated, and the procedure was completed after treatment of the superficial femoral artery. The patient was stable post-procedure and remained hospitalized for additional pre-scheduled procedures.
 
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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
sarah hicks
1225 old highway 8 nw
saint paul, MN 55112
MDR Report Key10750387
MDR Text Key213664298
Report Number3004742232-2020-00340
Device Sequence Number1
Product Code MCW
UDI-Device Identifier10852528005718
UDI-Public(01)10852528005718(17)210731(10)280700
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 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Model NumberVPR-GW-FLEX14
Device Catalogue Number7-10041-03
Device Lot Number280700
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2019
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: 10/28/2020 Patient Sequence Number: 1
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