Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC NESTER PLATINUM EMBOLIZATION COIL; KRD DEVICE, EMBOLIZATION, VASCULAR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK INC NESTER PLATINUM EMBOLIZATION COIL; KRD DEVICE, EMBOLIZATION, VASCULAR Back to Search Results
Model Number G52747
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event or Problem Description
The complainant reported that the nester platinum embolization coil was broken when the package was opened.It was further noted that the loading cartridge snapped 2cm (centimeters) below the hub.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NESTER PLATINUM EMBOLIZATION COIL
Common Device Name
KRD DEVICE, EMBOLIZATION, VASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7625881
Report Number1820334-2018-01965
Device Sequence Number1424670
Product Code KRD
UDI-Device Identifier00827002527478
UDI-Public(01)00827002527478(17)200205(10)5576463
Combination Product (Y/N)N
Initial Reporter CountryCA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Expiration Date02/05/2020
Device Model NumberG52747
Device Catalogue NumberMWCE-35-7-14-NESTER
Device Lot Number5576463
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/19/2018
Initial Report FDA Received Date06/21/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-