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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
Catalog Number IAB-S840C
Device Problem No Device Output (1435)
Patient Problems Myocardial Infarction (1969); No Consequences Or Impact To Patient (2199)
Event Date 07/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted in the patient and the staff noted there was no pressure wave pattern. As a result, the iab was changed out for a new iab and was able to get the wave pattern. There was a report of delay in therapy. There was no report of patient complication or serious injury and 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
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key8873483
MDR Text Key153698792
Report Number3010532612-2019-00248
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 07/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Catalogue NumberIAB-S840C
Device Lot Number18F18G0047
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2018
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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