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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET DYB INTRODUCER, CATHETER

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COOK INC MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET DYB INTRODUCER, CATHETER Back to Search Results
Model Number G02972
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/14/2022
Event Type  malfunction  
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Brand NameMICROPUNCTURE TRANSITIONLESS PEDAL ACCESS 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 Key15184172
Report Number1820334-2022-01318
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002029729
UDI-Public(01)00827002029729(17)250531(10)14761179
Combination Product (y/n)N
PMA/PMN Number
K172980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG02972
Device Catalogue NumberMPIS-401-PEDAL-NT-U-SST
Device Lot Number14761179
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received09/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2022
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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