FIBEROPTIX ULTRA 8 IAB: 8FR 30CC IPN000252 IAB-05830-LWS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for FIBEROPTIX ULTRA 8 IAB: 8FR 30CC IPN000252 IAB-05830-LWS manufactured by Arrow International Inc..

Event Text Entries

[185516685] (b)(4). See mdr# 3010532612-2020-00080 and (b)(4) as the report is related to the same patient.
Patient Sequence No: 1, Text Type: N, H10


[185516686] It was reported that the intra-aortic balloon (iab) had persistent possible helium loss 3 alarms. The iab have been inserted at bedside without fluoroscopy. The iab zeroed and inserted without issue. Once connected, the bpw was completely squared off for the first 3 beats and would issue the possible helium loss 3 alarm. The physician then stated that he could not see the tip on cxr. The physician feels the iab issue were patient related issues and not iab issues. As a result, the iab was removed and a new iab was inserted. There was no report of patient complications, serious injury or death. The patient had a delay in therapy. The patient did not require any increase in hemodynamic support during delays.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010532612-2020-00079
MDR Report Key9897229
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-30
Date of Report2020-03-10
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJONATHAN KIMCHAN
Manufacturer Street16 ELIZABETH DRIVE
Manufacturer CityCHELMSFORD MA 01824
Manufacturer CountryUS
Manufacturer Postal01824
Manufacturer G1ARROW INTERNATIONAL INC.
Manufacturer Street16 ELIZABETH DRIVE
Manufacturer CityCHELMSFORD MA 01824
Manufacturer CountryUS
Manufacturer Postal Code01824
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 30CC
Generic NameSYSTEM, BALLOON, INTRA-AORTIC
Product CodeDSP
Date Received2020-03-30
Model NumberIPN000252
Catalog NumberIAB-05830-LWS
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARROW INTERNATIONAL INC.
Manufacturer AddressREADING PA


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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