• 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 LIVER ACCESS AND BIOPSY SET DYB INTRODUCER, CATHETER

  • 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 LIVER ACCESS AND BIOPSY SET DYB INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problems Material Separation (1562); Migration (4003)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/14/2022
Event Type  Injury  
Manufacturer Narrative
Age at the time of event: age: "mid 80s". Initial reporter occupation: intervention radiologist. Pma/510(k) #: k171853. 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 the 5fr catheter included in the liver access and biopsy set sheared off during a transjugular liver biopsy procedure and remained inside the patient's pulmonary artery. The physician gained access to the hepatic vein using an mpb catheter and bentson wire. The bentson wire was then exchanged for an amplatz extra stiff wire for stability and the 7fr sheath with the 5fr hydrophilic catheter was advanced over the wire. Following placement in the target location, an attempt was made to remove the 5fr catheter in order to prepare for the biopsy device. Resistance was experienced and then subsided. Upon device removal, it was discovered that 2 cm of the distal portion of the 5fr catheter had sheared off. The catheter tip was visualized within the lumen of the hepatic vein. After the biopsy was completed, retrieval of the foreign body was attempted. After a couple of attempts with a snare, the catheter piece was dislodged and could no longer be visualized. Post procedure x-rays were performed and the catheter tip was visualized in a terminating portion of the right pulmonary artery. The physician discussed the issue with the patient and will follow up with the patient's primary care physician for next steps, if any. The patient was identified as a white male in his mid-(b)(6). The patient's currents status is reported to be "stable. " additional information regarding event details has been requested, but is currently unavailable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLIVER ACCESS AND BIOPSY SET
Type of DeviceDYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key13367175
MDR Text Key284528838
Report Number1820334-2022-00121
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberLABS-100-J-01
Device Lot Number13124124
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2020
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: 01/27/2022 Patient Sequence Number: 1
Treatment
BENTSON WIRE; COOK THSF-35-180-AES
-
-