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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 Chest Pain (1776); Perforation of Vessels (2135); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Vascular Dissection (3160)
Event Date 03/26/2021
Event Type  Death  
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.The device history record for this oad lot number has been reviewed.The review showed three previous instances of devices scrapped before distribution.It is unknown if the manufacturing scrap was related to the reported event.The device noted in this report met material, assembly, and quality control requirements prior to distribution.Csi id# (b)(4).
 
Event Description
The diamondback gen2 coronary orbital atherectomy device (oad) was selected for treatment of a type c, severely calcified, 70-80% stenosed lesion in the proximal and mid right coronary artery (rca).The vessel was 4.0mm in diameter and not tortuous.The lesion was wired via a radial approach.Intravascular ultrasound (ivus) was attempted, however, the ivus catheter was unable to advance in the vessel.A wire exchange was performed.The oad was inserted, and the crown jumped in a proximal to distal direction during the first treatment on low speed.Imaging showed the vessel was intact.On the third treatment, the crown jumped as the oad was moving in a distal to proximal direction.Imaging showed the vessel was intact.After the fifth treatment on low speed, the patient experienced chest pain, and morphine was administered.A perforation and a dissection were observed on imaging.Cardiac tamponade was performed, and the patient experienced hemodynamic deterioration due to the tamponade.The patient was intubated, and resuscitation was performed.Pericardiocentesis, intra-aortic balloon pump insertion, stent placement, and a blood transfusion were also performed.The patient passed away on (b)(6) 2021.The cause of death was reported to be perforation, cardiac tamponade, and cardiogenic shock.
 
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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
sarah hicks
1225 old highway 8 nw
saint paul, MN 55112
MDR Report Key11700314
MDR Text Key246465127
Report Number3004742232-2021-00143
Device Sequence Number1
Product Code MCX
UDI-Device Identifier10850000491417
UDI-Public(01)10850000491417(17)230131(10)365844-1
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P130005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial
Report Date 04/21/2021
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? Yes
Device Operator Health Professional
Device Expiration Date01/31/2023
Device Model NumberDBEC-125
Device Lot Number365844-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/26/2021
Initial Date FDA Received04/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/25/2021
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) Death;
Patient Age71 YR
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