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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 DBP-125SOLID145
Device Problem Unintended System Motion (1430)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/06/2018
Event Type  malfunction  
Manufacturer Narrative
The reported oad was received for analysis. The nose cone of the device was damaged as a result of an apparent impact, which may have been due to the device being shipped without the protective tray. Adhered biological material was observed on the driveshaft, crown, and proximal spring tip coils. The oad was found to function as intended with no abnormalities observed. The damage to the driveshaft and nose cone prohibited complete functional testing of the device, therefore the reported crown jumping was unable to be replicated. The reported guide wire was not received for analysis. At the conclusion of the device analysis investigation, the cause of the reported event 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), a device malfunction occurred leading to a procedural delay. The target lesions were located in the distal superficial femoral artery (sfa) and anterior tibial artery (at). When the oad was powered on to begin treatment, the crown was noted to move approximately 3 cm outside of operator control. The device was repositioned, however when it was powered on the crown jumped again. The lesion in the sfa was treated using one pass with the oad, however the uncontrolled movement occurred two more times. The oad was removed and the procedure was completed using balloon angioplasty. It was reported that the device issue led to a 30 minute procedural delay. No consequences to the patient were 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
MDR Report Key7477974
MDR Text Key107334951
Report Number3004742232-2018-00118
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133399
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 05/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Model NumberDBP-125SOLID145
Device Catalogue NumberDBP-125SOLID145
Device Lot Number213490
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2018
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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