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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
Catalog Number IAB-05830-LWS
Device Problems Off-Label Use (1494); Failure to Read Input Signal (1581); Intermittent Communication Failure (4038)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/07/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab), the chief of perfusion noted that they were losing the fiber optic signal, during and between insertion and beginning to pump. As a result, a new catheter was used. It was reported that the md used the iab in an off-label approach. There was no report of patient complication or serious injury and 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
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key8749318
MDR Text Key149673503
Report Number3010532612-2019-00203
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18F19B0001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2019
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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