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: BARD ACCESS SYSTEMS VACCESS CT W/8FR CF CATHETER INT; IMPLANTABLE PORT
  • 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
 

BARD ACCESS SYSTEMS VACCESS CT W/8FR CF CATHETER INT; IMPLANTABLE PORT Back to Search Results
Model Number 7480000
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Chest Pain (1776); Dizziness (2194); Injury (2348); Foreign Body In Patient (2687)
Event Date 12/29/2018
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
 
Event Description
It was reported that port catheter allegedly detached from the port body and migrated to the heart.It was further reported, the vascular resident removed the port body and catheter via snare.The patient reported no injury post removal procedure.
 
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: although the sample was not returned for evaluation, two x-rays were provided for review.The investigation is confirmed for the failure mode of catheter detachment as the catheter was found to have migrated to the svc and the right atrium, with no tubing left on the port connector.Image: a port catheter has the expected position.The cranial turn in the catheter tubing is not seen.The catheter tubing is not pushed very far into/on to the port connection making the connection between the two tenuous.Image: a break in the tubing is not seen.The port is in appropriate position.The catheter tubing has migrated to the svc and right atrium.No residual tubing is left on the port connector.On the fluoroscopic image of the catheter placement the catheter tubing is not pushed very far into the port connection.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.Potential causes include inadequate connection strength during routine use, incorrect connection method (e.G., advancing the catheter lock with black ring facing port, catheter lock crooked when advanced, catheter mushroomed), and use of sutures around/through the catheter.
 
Event Description
It was reported that port catheter allegedly detached from the port body and migrated to the heart.It was further reported, the vascular resident removed the port body and catheter via snare.The patient reported no injury post removal procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VACCESS CT W/8FR CF CATHETER INT
Type of Device
IMPLANTABLE PORT
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8283025
MDR Text Key134268912
Report Number3006260740-2019-00104
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741027475
UDI-Public(01)00801741027475
Combination Product (y/n)N
PMA/PMN Number
K063377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7480000
Device Catalogue Number7480000
Device Lot NumberRECW1007
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/02/2019
Initial Date FDA Received01/28/2019
Supplement Dates Manufacturer Received07/22/2019
Supplement Dates FDA Received07/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age30 YR
Patient Weight93
-
-