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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-150SOLID145
Device Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2020
Event Type  malfunction  
Manufacturer Narrative
The reported oad was received at csi for analysis, with the guide wire engaged. Visual examination revealed the guide wire was seized within the driveshaft tip bushing area. Embedded biological material was observed within the tip bushing area. Examination of the area of adhered material did not reveal any damage that would have contributed to the material accumulation. The returned guidewire could not be removed from the driveshaft. When tested, the oad functioned as intended. At the conclusion of the device investigation analysis, the report that the device became stuck on the wire was confirmed. The morphology and exact root cause of the accumulation was unknown. 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
The diamondback peripheral orbital atherectomy device was operated in the popliteal artery at low speed for three treatment passes. The brake was unlocked and the oad was advanced to the next lesion. Three treatment passes were performed at low speed. As the oad was removed from the vessel, it was stuck on the guide wire and the guide wire moved with the oad. Despite troubleshooting attempts, the oad remained stuck on the guide wire. A second wire was inserted into the guide catheter to maintain wire access and the oad and wire were removed together. The procedure was continued with balloon angioplasty. A delay of 30 minutes or greater occurred due to this issue.
 
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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
brittany leider
1225 old highway 8 nw
saint paul, MN 55112
6512591600
MDR Report Key10759125
MDR Text Key214613054
Report Number3004742232-2020-00325
Device Sequence Number1
Product Code MCW
UDI-Device Identifier10850000491196
UDI-Public(01)10850000491196(17)220630(10)332123
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190634
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 10/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2022
Device Model NumberDBP-150SOLID145
Device Catalogue Number7-10057-03
Device Lot Number332123
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2020
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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