MAUDE Adverse Event Report: MEDCOMP / MEDICAL COMPONENTS INC TITAN HD OR HEMOFLOW TUNNELED DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Device Problems Break (1069); Entrapment of Device (1212); Migration (4003); Physical Resistance/Sticking (4012)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 12/13/2021

Event Type  Injury  

Event Description

Medcomp 15.5f step-tip dialysis catheter broke at outside free-standing center while they were trying to remove it.Had been in place 2 years 9 months.Tip broke off and migrated to left pulmonary artery.Procedure aborted and pt sent here.Removed the tip from left pa and replaced "stuck" catheter.No sequelae.Fda safety report id # (b)(4).

• Brand Name: TITAN HD OR HEMOFLOW TUNNELED DIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): MEDCOMP / MEDICAL COMPONENTS INC; harleysville PA US
• MDR Report Key: 13026089
• MDR Text Key: 282584532
• Report Number: MW5106139
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American