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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. FIBEROPTIX ULTRA 8 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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ARROW INTERNATIONAL, INC. FIBEROPTIX ULTRA 8 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number IAB-05840-LWS
Device Problems Material Rupture (1546); Physical Resistance (2578)
Patient Problems Chest Pain (1776); Hemorrhage/Bleeding (1888); Mitral Regurgitation (1964); Myocardial Infarction (1969); Thrombus (2101); Stenosis (2263)
Event Date 07/11/2013
Event Type  Injury  
Event Description
Patient underwent cardiac catheterization and had an intra-aortic balloon pump (iabp) inserted in setting of a non-st-elevation myocardial infarction. Approximately 4 hours after insertion, the ccu nurse noted flecks of blood in the iabp tubing indicating balloon rupture. Helium was purged and the tubing was clamped. Attempts were made at the bedside to remove the catheter but resistance was encountered and the attempts were immediately stopped. Vascular surgery was consulted and the patient was taken to the operating room for a right groin exploration, removal of iabp, and repair of right external iliac artery. The patient was an elderly man with an extensive medical and cardiac history including end stage renal disease, atrial fibrillation, mitral valve insufficiency, aortic valve insufficiency and severe coronary artery disease requiring revascularization last year and again several months ago. He presented with chest pain and was found to have a non-st-elevation myocardial infarction. He underwent a cardiac catheterization, coronary angiogram and insertion of iabp via right femoral artery. He was found to have severe recurrent restenosis of his left anterior descending and left circumflex artery, and severe mitral regurgitation. At the time of the rupture of the iab, the patient began to experience cardiac and pulmonary decompensation. He was intubated and vasoactive medications were initiated. He was brought emergently to the or where he coded twice prior to the beginning of the case but was successfully resuscitated. The iab was found to be impacted in the distal aorta. Tpa was instilled into the balloon to soften the thrombus present. Surgical removal was initiated. The catheter was successfully removed and repair was completed. The patient coded at the end of the case as the skin was being closed and at the request of the family, no further resuscitation efforts were initiated.
 
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Brand NameFIBEROPTIX ULTRA 8
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
ARROW INTERNATIONAL, INC.
16 elizabeth dr.
chelmsford MA 01824
MDR Report Key5846198
MDR Text Key51152338
Report Number5846198
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial
Report Date 08/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberIAB-05840-LWS
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F16F0027
Other Device ID Number8FR/40CC FIBEROPTIX IAB
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/01/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer08/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/04/2016 Patient Sequence Number: 1
Treatment
CARDIAC DRUGS
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