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

Model Number F120080

Device Problems Difficult to Remove (1528); Unraveled Material (1664); Physical Resistance (2578)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/30/2016

Event Type  malfunction  

Event Description

The powerglide midline is an all-in-one setup that allows for accelerated seldinger placement of a midline catheter.It has a guide wire inside of the access needle and the catheter.Upon accessing the vein with the needle, the wire is threaded and then the catheter is threaded the rest of the way.The wire is then pulled out, then the needle, and we then secure the device.Upon pulling the wire back to remove it, there was resistance felt so i removed the catheter itself to see if that would help pull the wire out.The wire still would not come out of the patient's arm.I used an ultrasound to visualize the wire and saw it outside of the vein.X-rays were done, we spoke with ir to figure out a plan of action, the x-ray showed the wire inside the arm.Int.The radiologist came and removed the wire, a follow up x-ray was done and showed no remaining wire portions.The wire was unraveled upon removal.It is initially a braided wire and it became unraveled.This is what is assumed to be the reason for the wire becoming stuck.Manufacturer response for midline catheter 20g, powerglide pro midline catheter 20g (per site reporter): no response.

• Brand Name: POWERGLIDE
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 6233142
• MDR Text Key: 64176632
• Report Number: 6233142
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/28/2018
• Device Model Number: F120080
• Device Catalogue Number: F120080
• Device Lot Number: REAU1896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 79 YR
• Patient Weight: 78