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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-SC30-200
Device Problems Break (1069); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/24/2018
Event Type  malfunction  
Manufacturer Narrative
The reported oad was received for analysis. The driveshaft and saline sheath were noted to be kinked and deformed in multiple locations. This is consistent with attempting to pass the device through a guide sheath without success, however the root cause of the damage was unable to be conclusively determined. When tested, the oad functioned as intended with no anomalies noted. As the sheath and guide wire utilized during the procedure were not received for analysis, it was unable to be determined if they contributed to the reported event. At the conclusion of the device analysis investigation, the reported inability to pass the device through the guide sheath was unable to be 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. (b)(4).
 
Event Description
During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), the device was unable to pass through the sheath, resulting in a procedural delay. The oad was unable to pass through the 6f sheath in the distal superficial femoral artery. The sheath was replaced to a 7f sheath, however when loading the oad onto the guide wire it would not advance and the nose cone was noted to be damaged. Following a thirty minute delay, the device was replaced to complete the procedure and the patient remained in stable condition.
 
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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 Key7533792
MDR Text Key108907330
Report Number3004742232-2018-00136
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110389
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 05/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2020
Device Model NumberPRD-SC30-200
Device Catalogue Number70056-06
Device Lot Number207716
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2018
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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