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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 08/06/2018
Event Type  malfunction  
Manufacturer Narrative
The reported oad was returned for analysis with the guide wire utilized during the procedure engaged in the device. Resistance was felt when removing the guide wire from the driveshaft, and a fragment of fractured spring tip coil was found inside the driveshaft. Scanning electron microscopy was performed and identified the particles of radiopaque material inside the oad tip bushing, indicating that the oad was operated over the guide wire spring tip. Additionally, rotational marks and severe mechanical damage to the solder bond were noted, which exceeded the damage typically observed after a driveshaft is operated over a guide wire spring tip. It is possible that the spinning driveshaft made contact with the guide wire spring tip and continued to spin while making contact multiple times, however this could not be confirmed. At the conclusion of the device analysis investigation, the reported event of the device becoming stuck on the guide wire was confirmed. 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. Csi id# (b)(4).
 
Event Description
Following peripheral atherectomy treatment using a csi orbital atherectomy device (oad), the device was unable to be removed and was found to be stuck on the guide wire. The device and wire were removed together, the lesion was re-wired, and the procedure was completed with balloon angioplasty. No patient complications were reported. Upon analysis of the oad and guide wire, a fragment of the guide wire spring tip was found to be fractured and detached.
 
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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
MDR Report Key8056326
MDR Text Key127866133
Report Number3004742232-2018-00334
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 11/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2018
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 Manufacturer08/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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