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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000263
Device Problems Material Puncture/Hole (1504); Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/20/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) was implanted normally, and the intra-aortic balloon pump (iabp) was started. The iabp could not be started and alarmed for a "helium leak". The iab was repositioned repeatedly, and the balloon size was adjusted, with no change. As a result, the iab was removed and a new iab was used, using the same insertion site. There was no report of patient complications, serious injury or death.
 
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Brand NameREDIGUARD 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 Key10548909
MDR Text Key207393295
Report Number3010532612-2020-00253
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Model NumberIPN000263
Device Catalogue NumberIAB-S840C
Device Lot Number18F20A0038
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2020
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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