• 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 SIP-3000
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/07/2018
Event Type  malfunction  
Manufacturer Narrative
Analysis of the reported device is anticipated but has not yet begun. A supplemental report will be submitted when the device analysis is completed. (b)(4).
 
Event Description
The power cord of the orbital atherectomy device (oad) would not stay seated in the stealth saline infusion pump during a peripheral atherectomy procedure. The oad continuously slowed down and turned off. The procedure was successfully completed using another pump, and the patient was well. The procedure was delayed by 40 minutes.
 
Manufacturer Narrative
The device was received for analysis. Analysis identified the average retention force measurement for the oad power jack was below the specified requirement. As the oad was not returned for analysis, it could not be determined if it was damaged or contributed to the reported difficulties experienced. At the conclusion of the failure analysis investigation the reported event was confirmed. 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.
 
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 hwy 8 nw
st. paul MN 55112
MDR Report Key7843247
MDR Text Key119112974
Report Number3004742232-2018-00272
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
PMA/PMN Number
K133399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSIP-3000
Device Catalogue Number70057-03
Device Lot Number228791
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2018
Is This a Reprocessed and Reused Single-Use Device? No

-
-