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 DOME SUBQ PORT, GROSHONG; 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 DOME SUBQ PORT, GROSHONG; IMPLANTABLE PORT Back to Search Results
Model Number 0602850
Device Problems Disconnection (1171); Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889)
Patient Problems Thrombus (2101); Pericardial Effusion (3271)
Event Date 01/14/2020
Event Type  Injury  
Manufacturer Narrative
The lot number for the device was not provided, therefore, the device history records could not be reviewed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
 
Event Description
It was reported that seven years six months post port device implant, the catheter allegedly detached from the hub and migrated to the right heart, which was revealed through imaging, echocardiogram, and trans-esophageal diagnostic tests.It was further reported that the catheter was visualized in the right atrium with an attached density suspected to a portion of the catheter or thrombus.Reportedly, the port body and catheter were removed without complication.The patient was discharged home and reported to be hemodynamically stable.
 
Manufacturer Narrative
H10: manufacturing review: a lot history record could not be completed as the lot number was not provided.Investigation summary: one ti dome port with groshong catheter in two segments and one cathlock were returned for evaluation.Visual, microscopic, and functional evaluations were performed.The investigation is confirmed for a complete break in the catheter due to flexural fatigue, as a complete break in the catheter was identified approximately 1.7 cm from the distal end of the cathlock.Both cross-sectional surfaces at the complete break were observed to have a region that appeared to be smooth and polished with rounded edges and a region that appeared to be granular with sharper edges.The catheter lumen at the break appeared to have a flattened elliptical shape.A definitive root cause could not be determined.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that seven years six months post port device implant, the catheter allegedly detached from the hub and migrated to the right heart, which was revealed through imaging, echocardiogram, and trans-esophageal diagnostic tests.It was further reported that the catheter was visualized in the right atrium with an attached density suspected to a portion of the catheter or thrombus.Reportedly, the port body and catheter were removed without complication.The patient was discharged home and reported to be hemodynamically stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DOME SUBQ PORT, GROSHONG
Type of Device
IMPLANTABLE PORT
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9880959
MDR Text Key186603977
Report Number3006260740-2020-01055
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741025754
UDI-Public(01)00801741025754
Combination Product (y/n)N
PMA/PMN Number
K880571
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0602850
Device Catalogue Number0602850
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2020
Date Manufacturer Received08/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
XARELTO; XARELTO
Patient Outcome(s) Life Threatening; Other; Required Intervention;
Patient Age65 YR
Patient Weight57
-
-