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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 Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2018
Event Type  malfunction  
Manufacturer Narrative
Analysis of the reported device is in progress. A supplemental report will be submitted when the device analysis is completed. (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. Upon insertion, the peripheral device was difficult advance over the guide wire and required additional time to reach the lesion. The first target lesion was 100% stenosed and was treated with the oad. Following treatment, the device was unable to advance to the next lesion and was difficult to remove from the patient, leading to a procedural delay. The device and wire were removed together and the lesion was re-wired and the oad replaced to complete the procedure with additional atherectomy and balloon angioplasty.
 
Manufacturer Narrative
The reported oad was received for analysis. A guide wire was advanced through the device and met resistance proximal to the driveshaft tip bushing. Examination of the area revealed embedded biological material within the driveshaft filars. When this area was destructively removed, the guide wire was able to pass through the device with no resistance. The oad was then tested and found to function as intended with no anomalies noted. As the original guide wire utilized during the procedure was not returned for analysis, it could not be determined if it contributed to the reported event. At the conclusion of the device analysis investigation, the reported inability of the device to advance over the guide wire was confirmed to be due to embedded biological material in the driveshaft. However, the source of the biological material was unable to be determined. 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).
 
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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
MDR Report Key8054716
MDR Text Key126649707
Report Number3004742232-2018-00332
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
PMA/PMN Number
K133399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/26/2018
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 Expiration Date06/30/2020
Device Model NumberDBP-125SOLID145
Device Catalogue NumberDBP-125SOLID145
Device Lot Number230615
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2018
Is This a Reprocessed and Reused Single-Use Device? No

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