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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 IPN039787
Device Problem Fluid Leak (1250)
Patient Problem Vascular Dissection (3160)
Event Date 12/02/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). See mdr# 3010532612-2020-00388 ((b)(4)) as the report is related to the same patient.
 
Event Description
It was reported that when the intra-aortic balloon (iab) was in use, the staff noted small blood stains in the helium tube. The removal of the iab was attempted without success due to its incarceration in the left iliac-femoral axis. Contacted urgently the vascular surgery, the patient was transferred to an operative room to cut the artery and remove the device. The left inguinal incision allowed to appreciate the point of access of the iab at the origin of the superficial femoral. Despite a large transverse incision at the access, it was impossible to remove the balloon. An ultrasound study showed the presence of the iab balloon, proximally to the inferior mesenteric artery, incarcerated in the common iliac. No other iab was used.
 
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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
jonathan kimchan
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key11056888
MDR Text Key223175779
Report Number3010532612-2020-00389
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIT
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 12/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN039787
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F20E0041
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/29/2020
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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