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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNKNOWN

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COOK INC UNKNOWN Back to Search Results
Catalog Number UNKNOWN
Device Problems Material Separation (1562); Material Protrusion/Extrusion (2979)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/07/2019
Event Type  Malfunction  
Manufacturer Narrative

Common name & product code: unavailable as the device lot number, rpn, and gpn are unknown. Concomitant products: cook igtcfs-65-jp-jug-tulip. (b)(6). Pma/510(k) number: unavailable as the device lot number, rpn, and gpn are unknown. Device evaluated by mfg: device was initially evaluated at william cook europe, as wire guide was unknown and the product was returned along with the dilator included in the igtcfs-65-jp-jug-tulip set. The unknown wire guide will be returned to cook, inc for further evaluation. Cook, inc was made aware of this event on 10oct2019. 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, during a procedure to place a cook filter in the inferior vena cava of a patient of unknown age and gender, an unknown cook 0. 035 inch wire guide was used. The physician reportedly "felt something wrong" as the dilator of the filter set was advanced over the wire guide, outside the patient's body; however, the user continued to advance the device when it became stuck on the wire. The physician then attempted to remove the wire guide and felt as though the wire stretched, so the wire and dilator together from the body. An unknown multipurpose angiographic catheter was then used to complete the procedure "without problems". During evaluation of the device on 25jul2019 with the dilator of the filter set, the unknown wire guide was found to be inserted into both ends of the dilator. Several bends were noted along the wire, and the coils at the distal tip were separated from the weld ball and the tip was elongated. The safety wire protruded approximately 25 centimeters from the tip. The tip was slightly misshapen. There have been no adverse effects to the patient reported.

 
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Brand NameUNKNOWN
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9191548
MDR Text Key176441409
Report Number1820334-2019-02593
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/15/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/18/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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