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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 Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that after the catheter was implanted, the guidewire could not pass halfway through the catheter. As a result, a new catheter was used. 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
kaylia pen
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key13440831
MDR Text Key284972621
Report Number3010532612-2022-00015
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 Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN000263
Device Catalogue NumberIAB-S840C
Device Lot Number18F20G0008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2020
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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