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U.S. Department of Health and Human Services

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

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COOK INC MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER Back to Search Results
Model Number G48007
Device Problems Break (1069); Unraveled Material (1664)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/03/2022
Event Type  Injury  
Event Description
As reported, during an unspecified procedure involving the right femoral artery, a micropuncture transitionless stiffened cannula access set's wire unraveled and separated upon insertion, leaving a small fragment in the patient. Access was obtained in the femoral artery and the access site was reportedly calcified. Resistance was encountered upon both insertion and removal of the wire, which was manipulated and/or removed through the entry needle. The patient was transferred to another facility for removal of the wire fragment; however, the decision was made not to remove it. The fragment reportedly remains in the left groin, either extravascular to the femoral artery, or slightly intravascular. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
Occupation
=
lead tech. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available. This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others. Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
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Brand NameMICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA 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 Key15275358
MDR Text Key298394314
Report Number1820334-2022-01378
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002480070
UDI-Public(01)00827002480070(17)250610(10)14787155
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171275
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 09/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG48007
Device Catalogue NumberMPIS-501-10.0-SC-NT-SST
Device Lot Number14787155
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/23/2022 Patient Sequence Number: 1
Treatment
COPE WIRE
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