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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000257
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/18/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported that on (b)(6) 2021 dr. (b)(6) and team performed cabg to female patient and echo result low ejection fraction (below 20 %) so it's their protocol to put intra-aortic balloon (iab) as precaution. Nurses prepare all the iab tray properly and vacuum it to make sure there's no leak, they also implant the iab sheathless and connected to intra-aortic balloon pump (iabp); however within below one minute blood is flowing from drive line tubing and the iabp stopped pumping, so dr. (b)(6) quickly retract the iab and inspect the balloon. A leak was noted at the tip of the catheter. After such delay, it was deemed that the patient no longer need to be put on iabp so they proceed the surgery without it. There was no report of patient complications, serious injury or death.
 
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Brand NameULTRAFLEX IAB: 7.5FR 30CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
kaylia pen
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key12131355
MDR Text Key260358798
Report Number3010532612-2021-00181
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeID
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN000257
Device Catalogue NumberIAB-06830-U
Device Lot Number18F20K0001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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