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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROW INTERNATIONAL FIBEROPTIX ULTRA IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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TELEFLEX MEDICAL ARROW INTERNATIONAL FIBEROPTIX ULTRA IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number 8 IAB: 8FR 40CC
Device Problems Antenna, failure of (1029); Leak/Splash (1354); Material Rupture (1546); Rupture, cause unknown (1548); Device Contamination with Body Fluid (2317)
Patient Problems Ischemia (1942); Brain Injury (2219)
Event Date 11/17/2018
Event Type  Death  
Event Description
Iabp suddenly alarmed "pump failure" with no obvious source.There were a few microscopic speck of blood in the tube.Iabp was clamped.Saline was injected (<10 cc) and air was injected to inflated balloon and a small leak from balloon at the tip of catheter was noted c/w balloon rupture.Second catheter balloon rupture twice on two consecutive days (same pt).Unk if there was a failure in the catheter or the pump.
 
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Brand Name
FIBEROPTIX ULTRA IAB: 8FR 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
TELEFLEX MEDICAL ARROW INTERNATIONAL
reading PA 19605
MDR Report Key8137135
MDR Text Key129624437
Report Number8137135
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902007247
UDI-Public00801902007247
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number8 IAB: 8FR 40CC
Device Catalogue NumberIAB-05840-LWS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/17/2018
Event Location Hospital
Date Report to Manufacturer11/26/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age61 YR
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