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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4). There is an investigation ongoing into this reported complaint. A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.
 
Event Description
It was reported that the guidewire did not go through the catheter during insertion. It was noted that the lumen was obstructed in the middle. As a result, a new iab was used. There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4). There is an investigation ongoing into this reported complaint. A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.
 
Event Description
It was reported that the guidewire did not go through the catheter during insertion. It was noted that the lumen was obstructed in the middle. As a result, a new iab was used. There was no report of patient complications, serious injury or death.
 
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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
kaylia pen
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key13559399
MDR Text Key286072885
Report Number3010532612-2022-00035
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIN
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 01/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Model NumberIPN000262
Device Catalogue NumberIAB-S730C
Device Lot Number18F20C0037
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2020
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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