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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 No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2018
Event Type  malfunction  
Manufacturer Narrative
The reported guide wire was received for analysis with the oad utilized during the procedure. The spring tip of the guide wire was observed to have been fractured, and fragments of the spring tip were found inside the oad driveshaft. Analysis of the fragments found rotational damage indicating that the spinning oad driveshaft came into contact with the guide wire spring tip multiple times during the procedure. This may have been the cause of the device becoming stuck on the guide wire. The instructions for use for the reported device state "never advance the rotating crown to the point of contact with the guide wire spring tip. Distal detachment and embolization of the tip may result. " the material inspection report for the reported guide wire was unable to be reviewed, as the lot number was not provided. (b)(4).
 
Event Description
The csi peripheral diamondback orbital atherectomy device (oad) stopped spinning during the procedure and became stuck on the guide wire. The wire and device were removed and the procedure was completed without additional atherectomy. Upon analysis of the oad and viperwire guide wire, the tip of the guide wire was found to be fractured. There was no evidence that any portion of the wire remained in the patient and no patient complications have been reported.
 
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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
laramie otto
1225 old highway 8 nw
saint paul, MN 55112
6512591600
MDR Report Key8203721
MDR Text Key131716598
Report Number3004742232-2018-00391
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151260
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 12/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVPR-GW-14
Device Catalogue Number72023-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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