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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-125MICRO145
Device Problem Entrapment of Device (1212)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 12/03/2018
Event Type  Injury  
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 diamondback orbital atherectomy device (oad), the device became stuck in the lesion. The target lesion was 80% stenosed and located in the anterior tibial artery (at). The lesion was wired and the oad inserted, however it would not cross the lesion. Balloon angioplasty was performed, following which the oad was reinserted and successfully crossed the lesion. The lesion was treated with one pass at low speed and one pass at medium speed. When an attempt was made to remove the device, resistance was experienced. The device was tugged but was unable to be removed from the patient, and the guide wire was noted to be kinked. The guide wire was removed and a non-csi guide wire was inserted into the oad, however it coiled inside the device and was unable to be inserted. The oad was destructively cut and an additional wire was inserted in order to remove the device. Balloon angioplasty was performed to complete the procedure and the patient was 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
laramie otto
1225 old highway 8 nw
saint paul, MN 55112
6512591600
MDR Report Key8199467
MDR Text Key131502500
Report Number3004742232-2018-00383
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,Followup
Report Date 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Model NumberDBP-125MICRO145
Device Catalogue NumberDBP-125MICRO145
Device Lot Number243319
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2018
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 Manufactured10/04/2018
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: 12/27/2018 Patient Sequence Number: 1
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