MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERGLIDE; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number F120108PT-DOT PG PRO 20G 10CM RT

Device Problems Entrapment of Device (1212); Material Separation (1562); Failure to Advance (2524)

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

Event Date 03/04/2023

Event Type  malfunction  

Event Description

Patient admitted to hospital for right lower extremity pain and wound.Patient started on iv antibiotics at time of admission.On (b)(6) 2023, patient had to have a midline replaced.Vascular access device (vad) team member, reported to patient's room at 1530.Midline placement attempted; however, the catheter was not able to be advanced past 5cm.Procedure terminated and line pulled.Vad team member assessed catheter line and noted approximately 1.5cm of line was not present and potentially "sheared-off" into the patient's tissue.Vad team member immediately notified primary team physician and imaging ordered.Peripheral iv placed instead of midline at this time.X-ray performed and confirmed a 1.5cm linear radiopaque density along the medial distal portion of the upper arm.Ultrasound study performed and demonstrated a catheter shaped foreign body possibly within the superficial vessel.Cardiothoracic vascular team consulted and recommended surgical removal of foreign body.Patient refused surgery for removal.Risks explained by consult team and primary team of leaving foreign body in place.These risks included secondary infection and wound creation.Patient continued to refuse.

• Brand Name: POWERGLIDE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 16537196
• MDR Text Key: 311319784
• Report Number: MW5115719
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F120108PT-DOT PG PRO 20G 10CM RT
• Device Lot Number: REGX0602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 206 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White