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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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TELEFLEX INCORPORATED ARROW; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number IPN000260
Device Problems Material Twisted/Bent (2981); Noise, Audible (3273)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 11/28/2018
Event Type  malfunction  
Event Description
Intra-aortic balloon pump (iabp) arrhythmia alarm sounded with a message saying the catheter was kinked.When looking at the insertion site and following the tubing to find any source for the alarm, blood suddenly appeared in the helium/drive line.The rn immediately clamped the helium line and stat paged cardiology team.The balloon catheter was removed after attempts to manually remove any remaining helium from the balloon (confirming the balloon was deflated).The patient remains hemodynamically stable.The patient is sedated, with rass -3, so unable to accurately assess neurological status at this time.
 
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Brand Name
ARROW
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
TELEFLEX INCORPORATED
2400 bernville road
reading PA 19605
MDR Report Key8270410
MDR Text Key133855873
Report Number8270410
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902026804
UDI-Public(01)00801902026804
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN000260
Device Catalogue NumberIAB-06840-U
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/10/2018
Event Location Hospital
Date Report to Manufacturer01/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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