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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC AUTOMATED MANIFOLD KIT; CATHETER FOR CONTRAST INFUSION
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ACIST MEDICAL SYSTEMS, INC AUTOMATED MANIFOLD KIT; CATHETER FOR CONTRAST INFUSION Back to Search Results
Model Number BT2000
Device Problems Sticking (1597); Failure to Advance (2524); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/10/2017
Event Type  Injury  
Event Description
During cardiac cath procedure, the blade plunger would not allow contrast to move through system; pt undergoing pci with wires and balloon in place; cardiologist unable to verify pci results.Cardiologist pressed hand control device to deliver contrast and the black plunger got stuck midway within the manifold.At this point, no contrast or saline could be injected to pt; cath lab staff attempted to purge contrast and saline through manifold - "manifold failure" continued to display on screen.Final step to resolve issue: replaced acist apparatus with 4 port manifold to complete pci procedure.Total time 13.69 minutes before resolved.No harm to pt.
 
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Brand Name
AUTOMATED MANIFOLD KIT
Type of Device
CATHETER FOR CONTRAST INFUSION
Manufacturer (Section D)
ACIST MEDICAL SYSTEMS, INC
eden prairie MN
MDR Report Key6419271
MDR Text Key70482820
Report Number6419271
Device Sequence Number1
Product Code DXT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/18/2017
Device Model NumberBT2000
Device Catalogue Number014613
Device Lot Number28516E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/17/2017
Distributor Facility Aware Date03/10/2017
Event Location Hospital
Date Report to Manufacturer03/17/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age50 YR
Patient Weight87
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