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

Model Number CP00003

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/12/2024

Event Type  malfunction  

Event Description

Patient is an elderly person with pmh of mitochondrial complex 3 who presented to fv cardiac cath lab on [redacted date] for evaluation of her right internal jugular vein mediport after recent malfunctioning.A venogram through the existing catheter revealed a leak towards the entry site at the jugular.An exchange was completed under fluoroscopic guidance with no complications or significant blood loss.The patient was recovered and discharged to home later that same day.Manufacturer response for c.R.Bard powerport isp groshong 8fr titanium custom, powerport port isp groshong 8fr titanium custom (per site reporter).Manufacturer representative to pick up device after two week internal review.

• Brand Name: POWERPORT 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: 19049554
• MDR Text Key: 339468005
• Report Number: 19049554
• 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: 03/15/2024

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 Model Number: CP00003
• Device Catalogue Number: CP00003
• Device Lot Number: REGS1968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2024
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: White