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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC RING TRANSJUGULAR INTRAHEPATIC LIVER ACCESS AND BIOPSY SET DYB INTRODUCER, CATHETER

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COOK INC RING TRANSJUGULAR INTRAHEPATIC LIVER ACCESS AND BIOPSY SET DYB INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problems Flaked (1246); Improper or Incorrect Procedure or Method (2017)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/04/2021
Event Type  malfunction  
Manufacturer Narrative
Age: patient was in their 60's. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
It was reported a male patient required a ring transjugular intrahepatic liver access and biopsy set for a transjugular intrahepatic portosystemic shunt (tips) procedure. On the back table, the needle was loaded over the wire and some of the coating of the wire came off inside the needle. No coating flakes entered the patient. A second amplatz was opened for femoral access using an ultrasound device to complete the procedure successfully. As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
 
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Brand NameRING TRANSJUGULAR INTRAHEPATIC LIVER ACCESS AND BIOPSY SET
Type of DeviceDYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key11362213
MDR Text Key254392860
Report Number1820334-2021-00376
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002297692
UDI-Public(01)00827002297692(17)231203(10)13529947
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberRTPS-100-10.0
Device Lot Number13529947
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2020
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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