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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED FIBEROPTIX ULTRA; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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TELEFLEX INCORPORATED FIBEROPTIX ULTRA; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number IAB05840LWS
Device Problems Entrapment of Device (1212); Loss of Power (1475); Difficult to Remove (1528)
Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)
Event Date 06/07/2019
Event Type  Injury  
Event Description
Device was attempted first without successful obtainment of fiber optic signal.Only one balloon entered patient but continued issues with the fiber optic function of the pump.Helium loss alarm noted on iabp, blood in tubing, pump automatically shut off.Unsuccessful removal of iabp from femoral artery.Patient taken to cath lab to visualize under fluro.Unsuccessful attempt.Emergency surgery with cardiovascular surgeon for "repair of right femoral artery; intra-abdominal balloon pump impaction".Surgeon was unable to retrieve the internal portion of the balloon pump.The right groin was non-primarily closed with balloon pump cath.Patient required transfer to higher level of care.Reported to have lost limb (leg) due to malfunction of iapb and subsequent retained balloon tip.
 
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Brand Name
FIBEROPTIX ULTRA
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
TELEFLEX INCORPORATED
2400 bernville road
reading PA 19605
MDR Report Key8955941
MDR Text Key156300162
Report Number8955941
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 06/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberIAB05840LWS
Device Lot Number18F19A0016
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/11/2019
Event Location Hospital
Date Report to Manufacturer09/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention; Disability;
Patient Age24090 DA
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