• 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 TRANSJUGULAR LIVER ACCESS AND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY

  • 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 TRANSJUGULAR LIVER ACCESS AND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Hemoptysis (1887)
Event Date 05/14/2019
Event Type  Death  
Manufacturer Narrative
Date of death: date of death is likely (b)(6) 2019. Initial reporter occupation: unknown. Pma/510(k) #: preamendment. 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 a transjugular liver access and biopsy needle was used in an unknown patient for a trans-jugular renal biopsy. It was stated, ¿patient transfers (sic) from another institution for a trans-jugular renal biopsy (right internal jugular vein). After the puncture of the right internal jugular vein and the insertion of the sheath, the needle has crossed the sheath of the apical segment of the right upper lobe. When removing the biopsy needle, the patient presented with massive haemoptysis. Despite the intervention of the resuscitators the patient died. ¿ additional information regarding the event and patient outcome has been requested but is currently unavailable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRANSJUGULAR LIVER ACCESS AND BIOPSY NEEDLE
Type of DeviceFCG KIT, NEEDLE, BIOPSY
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC.
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key8650812
MDR Text Key146396246
Report Number1820334-2019-01340
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeFR
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 10/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date04/08/2022
Device Model NumberN/A
Device Catalogue NumberRMT-15-64.0-TJR
Device Lot NumberNS9651324
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/08/2019
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: 05/29/2019 Patient Sequence Number: 1
-
-