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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 DBE-150
Device Problems Entrapment of Device (1212); Separation Problem (4043)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2018
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 procedure, a device malfunction occurred with the stealth peripheral orbital atherectomy device (oad). The initial target lesion was a 100% stenosed, 100mm in length, in the anterior tibial artery with a diameter of 3. 5 mm. The initial lesion was treated with multiple passes of the device. The oad became stuck on the guide wire and the oad and guide wire were removed together resulting in loss of wire access. Re-wiring was performed for a second lesion located in the posterior tibial artery, resulting in a procedural delay of over 30 minutes. Prior to atherectomy of the second lesion, the sheath covering the driveshaft of the oad was noted to be loose. The oad was removed, and the second vessel was ballooned without using atherectomy. There were no patient complications from the procedure reported and the patient was discharged 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
sarah hicks
1225 old highway 8 nw
saint paul, MN 55112
MDR Report Key8197119
MDR Text Key131469584
Report Number3004742232-2018-00377
Device Sequence Number1
Product Code MCW
UDI-Device Identifier10852528005015
UDI-Public(01)10852528005015(17)211130(10)246776
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,Followup
Report Date 01/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2021
Device Model NumberDBE-150
Device Catalogue Number70056-01
Device Lot Number246776
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2018
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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