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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTL., INC. IAB: 8 FR - 40 CC FOS; INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM

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ARROW INTL., INC. IAB: 8 FR - 40 CC FOS; INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM Back to Search Results
Catalog Number IAB-05840-LWS
Device Problems Fluid/Blood Leak (1250); Gas/Air Leak (2946)
Patient Problem Mitral Insufficiency (1963)
Event Date 05/23/2014
Event Type  Injury  
Event Description
It was reported that while in the cardiothoracic surgery operating room the intra-aortic balloon (iab) was inserted sheathless cia the pt's right femoral artery.While in the cardiothoracic surgery intensive care unit the pt received constant intra-aortic balloon pump (iabp) therapy after mitral valve replacement and bypass surgery.The pt had to be reanimated.After reanimation blood residues were noted in the helium tube and the iabp (s/n (b)(4)) alarmed "helium leak." the md removed the iab and blood was noted in the balloon.During inspection of the pump serous fluids were found in the condensation trap.A new iab-05840-lws was inserted into the pt's left femoral artery and despite the blood noted in the pump, the md's decided to continue therapy with the same pump (s/n(b)(4)).Prior to the event the pt received iabp therapy for more than 10 hours.There was a delay / interruption in iabp therapy (timeframe is unk).There were reported pt complications and medical / surgical intervention was required and described as "cardiopulmonary resuscitation." add'l info received on (b)(6) 2014 stated that the pt vitality is unstable.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
IAB: 8 FR - 40 CC FOS
Type of Device
INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM
Manufacturer (Section D)
ARROW INTL., INC.
reading PA
Manufacturer (Section G)
ARROW INTL., INC.
9 plymouth st.
everett MA 02149
Manufacturer Contact
kathryn myers, regulatory associa
2400 bernville rd
reading, PA 19605
6103780131
MDR Report Key3885934
MDR Text Key4651899
Report Number1219856-2014-00107
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberIAB-05840-LWS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/27/2014
Initial Date FDA Received06/03/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age55 YR
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