MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPORT CLEARVUE ISP IMPLANTABLE PORT; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1608052

Patient Problem Failure of Implant (1924)

Event Date 07/21/2023

Event Type  malfunction  

Event Description

Patient arrived to the clinic to receive his chemotherapy.Patient here today for c2d1 taxol.Patient ambulatory upon arrival to clinic.Patient identity confirmed using two identifiers (name and dob), denies any new complaints.Labs and orders reviewed.Vs wnl.Implanted right port unable to be accessed.Patient sent to interventional radiology (ir) where it was determined her port was unable to be used.Patient rescheduled for next week.Patient called stating she was unable to get her chemo today due to issues with her port.Please call patient back to reschedule.Registered nurse (rn) confirmed with infusion that this patient was not able to get chemo due to port malfunction.She was rescheduled for chemo.She will need port replaced/fixed and ir was called to get this scheduled.Provider informed and stated she would put in urgent case request.Patient was called to be updated on all, she denies other need.See if patient needs pre-chemo visit with lab (has not had chemotherapy).If so schedule.Sent to radiology fluoroscopy to access port and assess.The port per radiographs was accessed properly within the port which appeared intact.However it would not flush nor allow infusion.After attempts to open the port-a-cath, decision made to have interventional radiology reassess.Patient will need iv access for chemotherapy.Patient initially had port implanted, and had to have port removed, and a new port placed.

• Brand Name: POWERPORT CLEARVUE ISP IMPLANTABLE PORT
• Type of Device: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 18290837
• MDR Text Key: 330043944
• Report Number: 18290837
• Device Sequence Number: 1
• Product Code: LJT
• 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: 10/05/2023

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: 1608052
• Device Catalogue Number: 1608052
• Device Lot Number: REHN2502
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA
• Patient Sex: Female
• Patient Weight: 118 KG
• Patient Race: White