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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000254
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that blood was seen in the intra-aortic balloon (iab) catheter, which could indicate a breakdown in balloon integrity. Additional information was received that therapy was discontinued soon after the helium leak alarm could not be resolved. There was no report of patient complications, serious injury or death.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
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 Key12683462
MDR Text Key277962313
Report Number3010532612-2021-00348
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN000254
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F21D0005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2021
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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