• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Model Number PRD-SC30-125
Device Problem Entrapment of Device (1212)
Patient Problems Foreign Body In Patient (2687); Vascular Dissection (3160)
Event Date 02/16/2022
Event Type  Injury  
Event Description
A stealth peripheral orbital atherectomy device (oad) was used via femoral access and contralateral approach. The distal target vessel was approximately 2-2. 5mm in diameter, and the lesion was a chronic total occlusion. The lesion was heavily calcified with no tortuosity. The first low-speed treatment was successful. A medium-speed treatment was initiated, and an unexpected audible noise was observed. The oad could not be removed past the proximal portion of the anterior tibial artery and was apparently trapped in a dissection plane. After multiple attempts at pulling the oad, the attempt was abandoned. The physician attempted to obtain pedal access to try to snare or break the oad free. Pedal access was not an option due to vessel characteristics. As a last effort, the driveshaft and saline sheath were cut so that the physician could use a 100cm guide catheter over the saline sheath to try to capture the crown. The attempt was not successful. The physician then unsuccessfully attempted to wire the at and pass a small balloon to try and free the crown. The decision was made to make arrangements with a surgeon and a transport team in order to move the patient safely to the or with the 6fr sheath, saline sheath, and driveshaft still in the patient. The patient was transported for surgical removal and was recovering as of on (b)(6) 2022.
 
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. 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. It was not clear whether or not the device had caused the initial dissection. Therefore, csi could not be ruled out as contributory to that specific adverse event. Csi id: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL ATHERECTOMY DEVICE
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul MN 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul MN 55112
Manufacturer Contact
morgan hill
1225 old hwy 8 nw
st. paul, MN 55112
MDR Report Key13801804
MDR Text Key287536250
Report Number3004742232-2022-00063
Device Sequence Number1
Product Code MCW
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRD-SC30-125
Device Catalogue Number7-10059-02
Device Lot Number356286-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/02/2021
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: 03/17/2022 Patient Sequence Number: 1
-
-