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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000262
Device Problem Difficult to Advance (2920)
Patient Problem Needle Stick/Puncture (2462)
Event Date 10/18/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) was unable to be passed through the sheath. As a result, the user used a different iab of the same size from stock. The second iab was inserted at a different insertion site. There was no report of patient complications.
 
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Brand NameREDIGUARD IAB: 7FR 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
jonathan kimchan
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key10823502
MDR Text Key215886789
Report Number3010532612-2020-00330
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Model NumberIPN000262
Device Catalogue NumberIAB-S730C
Device Lot Number18F20A0008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2020
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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