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

Model Number F118101T

Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/26/2022

Event Type  malfunction  

Event Description

The vascular access team nurse attempted insertion under ultrasound guidance of a powerglide pro catheter in patient's right upper arm cephalic vein.The vein was accessed with a needle and good blood return was obtained.The guidewire was advanced without initial resistance, but met resistance while advancing the catheter.The nurse stopped the attempt to advance the catheter, and made a slight change in angle of the device before further attempts to advance, but this was ineffective.The device was removed from the patient while extending the catheter to shield the needle as the device was withdrawn.Upon inspection, the catheter appeared to be intact.The entire device was deposited in sharps container in the patient's room.A repeat ultrasound assessment was performed and found vessel difficult to visualize and an abnormal appearance suspicious for foreign object retention.Patient reported no discomfort in affected area.Overall patient condition was unchanged.Immediately reported my findings and concerns to the intensivist who ordered a follow up ultrasound of the affected area.The us (ultrasound) of the right upper extremity revealed a thrombosis of the cephalic vein on the right side in the arm and a 3 cm segment of the catheter was noted within the cephalic vein.An mri x-ray was performed and confirmed the retained fragment.The patient underwent a venogram by interventional radiologist and the fragment was removed.Fragment retained by hospital.

• 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: 14572955
• MDR Text Key: 293159416
• Report Number: 14572955
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/27/2022,05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F118101T
• Device Catalogue Number: F118101T
• Device Lot Number: REFZ1119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Weight: 89 KG
• Patient Race: White