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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH PKGD: WEDGE 5 FR 60CM; CATHETER, FLOW DIRECTED
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ARROW INTERNATIONAL LLC ARROW CATH PKGD: WEDGE 5 FR 60CM; CATHETER, FLOW DIRECTED Back to Search Results
Catalog Number AI-07123
Device Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2024
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported " during the procedure according to ifu, the md found the balloon could not pass following the wire.So the md opened up the new kit to finish the procedure." no patient injury or consequence reported.Patient condition reported as "fine".
 
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Brand Name
ARROW CATH PKGD: WEDGE 5 FR 60CM
Type of Device
CATHETER, FLOW DIRECTED
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
taliah shabazz
3015 carrington mill blvd
morrisville 27560
MDR Report Key18672745
MDR Text Key334981255
Report Number3010532612-2024-00116
Device Sequence Number1
Product Code DYG
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K892530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 01/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2023
Device Catalogue NumberAI-07123
Device Lot Number16F22F0034
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/23/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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