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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER DYB INTRODUCER, CATHETER

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COOK INC PERFORMER INTRODUCER DYB INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hematoma (1884)
Event Date 07/21/2020
Event Type  Injury  
Manufacturer Narrative
It is unknown if the device will be returned. Pma/510(k) number
=
pre-amendment. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
 
Event Description
As reported to cook by another manufacturer, a performer introducer was used during placement of another manufacturer's pulmonary artery pressure monitoring device. The intended procedure was completed without incident and the patient completed two hours of flat bedrest postoperatively. No lines remained in the access site. Upon standing for the first time after the procedure, a pop was heard and the groin incision site began to bleed. Manual pressure was held for twenty minutes and a compression device was used at 80mmhg for two hours. The patient was kept overnight for observation. The hematoma had resolved the next morning and the patient's vital signs and hemoglobin were reportedly stable. The patient was discharged without incident. There has been no alleged malfunction of the cook performer introducer. Additional information has been requested, but is not available at this time.
 
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Brand NamePERFORMER INTRODUCER
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 Key11101407
MDR Text Key224569983
Report Number1820334-2020-02399
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002073692
UDI-Public(01)00827002073692(17)230602(10)13144296
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberRCF-12.0-38-J
Device Lot Number13144296
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/02/2020
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: 12/31/2020 Patient Sequence Number: 1
Treatment
ABBOTT CARDIOMEMS, FEM STOP
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