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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE

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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE Back to Search Results
Model Number DBEC-125
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Cardiogenic Shock (2262); Diaphoresis (2452)
Event Date 10/26/2021
Event Type  Injury  
Event Description
A diamondback coronary orbital atherectomy device (oad) was selected for treatment of the left anterior descending artery.The oad was traversed more than 3 mm per second, and at the lesion the oad jumped forward.Treatment was stopped after 30 seconds and the oad was removed.Imaging revealed a non-flow limiting dissection and the area was pre-dilated with a balloon and stent placement was performed.Intravascular ultrasound revealed a hematoma outside the stent.The wire and guide catheter were removed.Later that evening, the patient went into cardiogenic shock and became hypotensive and diaphoretic.An echocardiogram revealed a perforation was the cause of the cardiogenic shock.The patient also had cardiac tamponade.Placement of stents and pericardial drains were performed to resolve the perforation and tamponade events.The patient was discharged on (b)(6) 2021 without further complications.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Per the physician, the hematoma and dissection events may have been caused by the csi device, however the physician stated that the patient was prone to dissections.The physician declined to offer an opinion as to what caused the perforation, cardiogenic shock, tamponade and atrial fibrillation events.(b)(4).
 
Manufacturer Narrative
Updated fields: a3, a6, b4, g3, g6, h2, h10 csi id:(b)(4).
 
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Brand Name
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
Type of Device
CORONARY 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 Key12835857
MDR Text Key280961928
Report Number3004742232-2021-00381
Device Sequence Number1
Product Code MCX
UDI-Device Identifier10850026568087
UDI-Public(01)10850026568087(17)230831(10)393314-1
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/24/2021
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? No
Device Operator Health Professional
Device Expiration Date08/31/2023
Device Model NumberDBEC-125
Device Catalogue Number7-10060-09
Device Lot Number393314-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/26/2021
Initial Date FDA Received11/18/2021
Supplement Dates Manufacturer Received11/18/2021
Supplement Dates FDA Received11/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/07/2021
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 Age77 YR
Patient SexFemale
Patient RaceWhite
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