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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 Name
ARROW 8FR 30 CC IAB FIBEROPTIX
Type of Device
SYSTEM, 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
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Lot Number18F19M0015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/02/2021
Date Report to Manufacturer09/17/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/17/2021
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age24820 DA
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