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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW 8FR 30 CC IAB FIBEROPTIX SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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TELEFLEX INCORPORATED ARROW 8FR 30 CC IAB FIBEROPTIX SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Lot Number 18F19M0015
Device Problems Material Rupture (1546); Inappropriate Waveform (2536); Noise, Audible (3273)
Patient Problem Insufficient Information (4580)
Event Date 06/18/2021
Event Type  malfunction  
Event Description
Fiberoptic intra-aortic balloon (iab) showed weak waveform (fiber optic sensor). At end of case the low helium alarm came on. Blood found inline. Heard hissing at groin site ie balloon rupture noted. Doctor returned stat to central venous line (cvl) and new iabp inserted.
 
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Brand NameARROW 8FR 30 CC IAB FIBEROPTIX
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key12487565
MDR Text Key271918741
Report Number12487565
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 Risk Manager
Type of Report Initial
Report Date 09/02/2021,06/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number18F19M0015
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/02/2021
Event Location No Information
Date Report to Manufacturer09/17/2021
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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