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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000252
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the hospital staff that during insertion, the intra-aortic balloon (iab) was noted kinked. As a result, the iab was removed and a new iab was inserted at the same insertion site. There was no report of patient complications, serious injury or death.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 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
2400 bernville road
reading, PA 19605
MDR Report Key11792583
MDR Text Key249677240
Report Number3010532612-2021-00128
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN000252
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18F20G0030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2020
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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