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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 IPN038102
Device Problems Fluid Leak (1250); Material Rupture (1546)
Patient Problem Needle Stick/Puncture (2462)
Event Date 11/05/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Other remarks: see mdr# 3010532612-2020-00363 (b)(4) as the report is related to the same patient.
 
Event Description
It was reported that intra-aortic balloon (iab)was placed into the patient without any problems. The intra-aortic balloon pump (iabp) was started and ran without problems. Six hours later they were called, as blood was noticed in the helium tube. The iabp was stopped immediately, and a new iab was inserted in a new insertion site. The patient's aorta was very calcified, and the doctor decided to insert another iab due to the critical situation of the patient.
 
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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 Key10864216
MDR Text Key217080616
Report Number3010532612-2020-00362
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Model NumberIPN038102
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F19F0093
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2019
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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