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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 G07919
Device Problem Split (2537)
Patient Problem No Patient Involvement (2645)
Event Date 03/19/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Pma/510(k) number
=
pre-amendment. Device evaluation is in progress. Conclusion is not yet available. 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 initially reported that the performer introducer was found damaged in the package. There was no patient contact. Upon return of the device to the manufacturer, a split was observed to the tip, or distal end, of the complaint device.
 
Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, manufacturing instructions, quality control, specifications, and a visual inspection and functional evaluation of the returned device were conducted during the investigation. The visual inspection of the returned device confirmed that the distal end of the dilator was partially compressed, with a 1 mm split present as well. The dilator accepted a 0. 035¿ wire guide with a smooth transition. Additionally, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. A review of the device history record showed no nonconforming events which could contribute to this failure mode. It should be noted there were no other reported complaints for this lot number. Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined. We will continue to monitor for similar complaints. Per the quality engineering risk assessment, no further action is required.
 
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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 Key7468680
MDR Text Key106756980
Report Number1820334-2018-00735
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG07919
Device Catalogue NumberRCFW-6.0-35-RB
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2017
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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