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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 No Device Output (1435); Failure to Zero (1683)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/19/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that when the intra-aortic balloon (iab) was connected to the intra-aortic balloon pump (iabp), the iab did not zero. The clinical technician tried a couple more times and had plugged the iab into another pump, but no change. As a result, the iab (30cc) was exchanged for another iab (40cc). The 40cc iab was used as there was not another 30cc iab available. Placement was checked to ensure left subclavian artery and renal arteries where not covered by longer balloon. Iabp (wave/fo) worked very well and patient had surgery and was discharged. 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 Key8515830
MDR Text Key142045776
Report Number3010532612-2019-00103
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18F18A0048
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2018
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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