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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 Problems Entrapment of Device (1212); Unintended System Motion (1430)
Patient Problem Vascular Dissection (3160)
Event Date 04/12/2018
Event Type  Injury  
Manufacturer Narrative
The reported orbital atherectomy device (oad) was returned with the guide wire engaged and stuck in the device. Detailed analysis revealed adhered and embedded biological material on the driveshaft and on the guide wire which prevented removal of the guide wire from the device. There was no damage observed with the device or the guide wire that would have contributed to the reported event. When tested the device spun during all three speeds and functioned with no abnormalities observed. The morphology of the biological material is not known and the exact root cause of accumulating tissue remains unknown. Examination in the areas of the adhered tissue did not reveal any damage that would have contributed to the accumulation. At the conclusion of the device analysis investigation, the reported event of the oad becoming stuck on the guide wire was confirmed. However, the root cause of the device becoming stuck on the guide wire, crown jumping, and dissection could not be conclusively determined. (b)(4).
 
Event Description
During an atherectomy procedure using a csi peripheral orbital atherectomy device (oad), a dissection occurred. The target lesion was in the tibial-peroneal trunk (tpt) artery. The crown of the device was noted to jump back at the completion of the passes through the lesion. Upon removal of the device, it was noted to be stuck on the guide wire. The device and the wire were removed together and a dissection was noted to have occurred. The dissection was treated with the placement of a stent. The patient was reported to be in stable condition after the procedure and no further patient complications have been reported as a result of this event.
 
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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
alyssa ikeri
1225 old highway 8 nw
saint paul, MN 55112
6512591600
MDR Report Key7487836
MDR Text Key107382333
Report Number3004742232-2018-00123
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 05/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Model NumberDBP-125SOLID145
Device Catalogue NumberDBP-125SOLID145
Device Lot Number213398
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/12/2018
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

Patient Treatment Data
Date Received: 05/04/2018 Patient Sequence Number: 1
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