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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 Problems Vessel Or Plaque, Device Embedded In (1204); Vascular Dissection (3160); No Code Available (3191)
Event Date 04/17/2019
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 procedure for a patient with critical limb ischemia, the diamondback peripheral orbital atherectomy device (oad) was used to treat diffuse lesions. The patient had diffusely diseased lesions throughout the posterior tibial artery (pt), anterior tibial artery (at), and pedal loop arteries. The calcification of the lesions were moderate to severe with 75-95% stenosis depending on the area. The pt was treated with non-csi directional atherectomy, and then the entire diseased area was wired. Orbital atherectomy with the csi oad was used in the pt, and on the third treatment pass, the crown of the oad became stuck in a lesion in the plantar vessel distal to the treatment area and stopped spinning. It was noted that there was quite a bit of vessel spasms occurring during the procedure. The driveshaft and saline sheath of the oad were cut, and a non-csi catheter was used to remove the oad from the vessel. After the oad was removed, angiographic imaging was performed and a large dissection was observed affecting a long section of the lateral plantar artery. It was unknown if the dissection occurred before or after the removal of the oad. No additional intervention was performed related to the dissection. Balloon angioplasty was used to complete the procedure, and the procedure was deemed successful through ultrasound and pulsations observed in the foot indicating the patient was revascularized. The patient left the procedure in good status.
 
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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
sarah hicks
1225 old highway 8 nw
saint paul, MN 55112
MDR Report Key8579085
MDR Text Key144006488
Report Number3004742232-2019-00123
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 05/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2020
Device Model NumberDBP-125MICRO145
Device Catalogue NumberDBP-125MICRO145
Device Lot Number248308
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2018
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: 05/03/2019 Patient Sequence Number: 1
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