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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 G07605
Device Problem Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 that prior to a transcatheter arterial embolization (tae) procedure, the performer introducer package was opened and the tip of the dilator was observed to be damaged/ split. It was noted that there was a slight edge on the tip. Another introducer of the same lot number was used to successfully complete the procedure. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand NamePERFORMER INTRODUCER
Type of DeviceDYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key7193180
MDR Text Key97549499
Report Number1820334-2018-00169
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002076051
UDI-Public(01)00827002076051(17)200508(10)7857036
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG07605
Device Catalogue NumberRCF-5.0-35-J
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/08/2017
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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