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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 Entrapment of Device (1212)
Patient Problem Vascular Dissection (3160)
Event Date 04/19/2018
Event Type  Injury  
Manufacturer Narrative
The reported oad was returned for analysis with the guide wire engaged in the device.The guide wire was removed from the oad with some resistance.Adhered biological material was found on the driveshaft and crown, however the material did not prevent the guide wire from passing through the driveshaft.The source of the biological material is unknown.There was no additional damage observed with the device or guide wire which would have contributed to the reported event.When tested, the oad functioned as intended with no anomalies noted.At the conclusion of the device analysis investigation, the reported event was unable to be confirmed.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
During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), a dissection occurred.Lesions in three segments of the anterior tibial artery were treated using multiple passes with the oad on low, medium and high speeds.When the oad was activated again following a rest period, the device stalled and became stuck on the guide wire.The oad and wire were removed together and when imaging was performed a dissection was noted.Bypass surgery was performed to resolve the dissection.
 
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Brand Name
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of Device
PERIPHERAL 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
MDR Report Key7522852
MDR Text Key108545652
Report Number3004742232-2018-00133
Device Sequence Number1
Product Code MCW
UDI-Device Identifier10852528005244
UDI-Public(01)10852528005244(17)181231(10)178639
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 Physician
Type of Report Initial
Report Date 05/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date12/31/2018
Device Model NumberDBP-125SOLID145
Device Catalogue NumberDBP-125SOLID145
Device Lot Number178639
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/19/2018
Initial Date FDA Received05/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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