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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW / ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORAT BALLOON CATHETER; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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ARROW / ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORAT BALLOON CATHETER; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problem Material Rupture (1546)
Patient Problem Loss of consciousness (2418)
Event Date 03/19/2021
Event Type  Death  
Event Description
Pt received a cabg by dr at (b)(6) 2021.He had to be placed on to bypass twice during the surgery and was brought out to the cticu with a balloon pump (iabp) at 1400.At 2245, the iabp began alarming helium loss.The iabp engineer and ct surgery on call were at the bedside at 2249.The balloon was pulled out of the patient at 2300 by dr after discovering that the balloon had ruptured.Dr was notified.At 0000 on (b)(6) 2021, it was discovered that the patient's pupils were sluggish and patient was not responding to deep distal stimulation.Dr was aware.Patient went for multiple ct scans at 0125 and 0540.Neurology was consulted after the first scan was concerning for air emboli, thrombus, and stroke.At 0851 the patient's pupils were nonreactive.The patient's family was called in and the patient was made cmo.Fda safety report id#: (b)(4).
 
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Brand Name
BALLOON CATHETER
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
ARROW / ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORAT
MDR Report Key11655223
MDR Text Key245332735
Report NumberMW5100710
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age69 YR
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