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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED FIBEROPTIX IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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TELEFLEX INCORPORATED FIBEROPTIX IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number IPN915319
Device Problem Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 03/06/2021
Event Type  malfunction  
Event Description
Arrow iabp inserted during cath lab procedure. Post procedure, poor augmentation, poor arterial waveform being transduced, no fibro optics. Blood noted in the helium balloon line.
 
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Brand NameFIBEROPTIX IAB: 8FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key11526567
MDR Text Key241005827
Report Number11526567
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN915319
Device Catalogue NumberIAB-05840-LWS
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/16/2021
Event Location No Information
Date Report to Manufacturer03/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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