• 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 360 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 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Model Number DBP-125SOLID145
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Event Date 10/31/2019
Event Type  Injury  
Manufacturer Narrative
The reported oad was received for analysis. Visual examination revealed a gap in the set adhesive for the motor cable. During functional testing a saline solution was poured onto the motor housing, and the speed of the oad was observed to fluctuate as a result of the moisture ingress. All expected led lights were observed to be visibly lit. At the conclusion of the failure analysis investigation, the reported events that the oad sounded as though it were losing speed and the low speed button began blinking were partially confirmed. The motor did not fully stop spinning during analysis, however it spun inconsistently and was unable to maintain speeds. The report that the patient became symptomatic during the procedure occurred prior to the reported device issue. The device analysis was unable to confirm if the device issues experienced could cause or contribute to the patient issues reported. 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: 07872.
 
Event Description
The peripheral diamondback orbital atherectomy device (oad) was operated on all speeds during treatment to the proximal side of the superficial femoral artery (sfa) with no issues observed. The oad was advanced to the distal side of the sfa and the patient presented with hypotension and bradycardia. Administration of pharmacological therapy was performed to stabilize the patient, and the treatment was continued. The oad sounded as though it were losing speed and the low speed button began blinking. Troubleshooting attempts to power the oad on and off were unsuccessful, and a second oad was opened to complete the procedure. The reported issues with the oad occurred after the reported patient adverse event and there is no indication that the two events are related. The patient was reportedly well. Per the opinion of the physician, it was unclear why the patient became symptomatic during the procedure. It was reported that the patient has experienced hypotension in previous procedures.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
brittany leider
1225 old highway 8 nw
saint paul, MN 55112
6512591600
MDR Report Key9383875
MDR Text Key168244544
Report Number3004742232-2019-00309
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2021
Device Model NumberDBP-125SOLID145
Device Catalogue NumberDBP-125SOLID145
Device Lot Number279384
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/27/2019 Patient Sequence Number: 1
-
-