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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-125MICRO60
Device Problem Entrapment of Device (1212)
Patient Problem Vascular Dissection (3160)
Event Date 08/25/2020
Event Type  Injury  
Manufacturer Narrative
The reported oad was received at csi for analysis.Visual examination revealed adhered biological material on the driveshaft and crown.The material prevented a guide wire from passing through the area.When tested for functionality, the oad functioned as intended.At the conclusion of the device analysis investigation, the report that the device was stuck on the wire and a dissection occurred was partially confirmed.There was no damage observed with the oad that would have contributed to the dissection event.It is possible that the biological material accumulation on the driveshaft or crown contributed to the dissection, however this could not be confirmed.The report that the device was stuck on the wire was confirmed, due to the adhered material observed which prevented a guide wire from passing through.Further examination of the area of adhered material did not reveal any damage that would have contributed to the accumulation.The morphology and exact root cause of the accumulation was unknown.As the original guide wire was not returned, it could not be determined if it contributed to the reported event.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.Csi id: 09004.
 
Event Description
A diamondback peripheral orbital atherectomy device (oad) was selected for treatment of lesions in the popliteal (pt) and anterior tibial (at) arteries.Pedal access via the at was obtained.Orbital atherectomy was successfully completed in the pt and treatment was continued in the at.The oad was operated on low and medium speed without issue, however the oad stopped spinning on high speed.Per the opinion of the physician, the device was stuck on the wire.A troubleshooting attempt to spin the device off of the wire was performed but was unsuccessful.The oad and wire were removed together.An angiogram was performed and revealed a type c dissection in the at artery.Two four-minute balloon inflations were performed to tamponade the dissection.A final angiography showed that the dissection was resolved.After the procedure a pressure dressing was applied, and blood thinners were administered to ensure the dissection was resolved.The patient was reported to be fine the following day.Per the opinion of the physician, the oad may have accumulated tissue while stuck on the wire or during removal and contributed to 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
brittany leider
1225 old highway 8 nw
saint paul, MN 55112
6512591600
MDR Report Key10572724
MDR Text Key208127563
Report Number3004742232-2020-00280
Device Sequence Number1
Product Code MCW
UDI-Device Identifier10852528005206
UDI-Public(01)10852528005206(17)211231(10)302752
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 Physician
Type of Report Initial
Report Date 09/23/2020
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 Health Professional
Device Expiration Date12/31/2021
Device Model NumberDBP-125MICRO60
Device Catalogue NumberDBP-125MICRO60
Device Lot Number302752
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/25/2020
Initial Date FDA Received09/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/11/2019
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;
Patient Age64 YR
Patient Weight80
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