MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. LOW-PROFILE IMPLANTABLE PORT,HICKMAN SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0603880
Medical Device Problem Codes	Difficult to Flush (1251); Fracture (1260); Material Separation (1562); Suction Problem (2170); Migration (4003)
Health Effect - Clinical Codes	Stenosis (2263); Swelling/ Edema (4577)
Date of Event	06/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through litigation process that, on (b)(6) 2011, a patient was implanted with a port via the left subclavian vein for as the patient was in need for central venous access to treat iron deficiency.Approximately eleven months and eight days later on (b)(6) 2022, that catheter was allegedly fractured and the fragment migrated to right atrium.It was further reported that the port stopped functioning as blood could not be aspirated and flushing was unsuccessful.Imaging, including ct of the neck with contrast, showed severe narrowing of the left brachiocephalic and subclavian veins around the port catheter with collateral formation throughout the neck, chest wall, and mediastinum this may be responsible for the patient's left upper extremity swelling.However, the current status of the patient remains unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation, medical record was provided for review.The medical records allege that the patient previously had a right sided port that became painful and required removal.A bardport m.R.I.Low profile implantable port (catalog 0603880, lot reug0781) was later implanted in the left chest to provide central venous access for treatment of iron deficiency.The procedure was performed using the seldinger technique.The left subclavian vein was successfully cannulated, and a guidewire was advanced into the superior vena cava under fluoroscopic guidance.An introducer and venous dilator were placed without resistance.The catheter was then tunneled to a port pocket created along the pectoralis muscle, the reservoir was secured, and the site was appropriately dressed with sterile strips.Approximately 10 years and 11 months after the implantation, the port malfunctioned, with inability to aspirate blood and unsuccessful flushing.Imaging performed the same day reported that the catheter had allegedly fractured, and a distal catheter fragment had migrated to the right atrium.Ct imaging of the neck with contrast revealed severe narrowing of the left brachiocephalic and subclavian veins surrounding the catheter, with extensive collateral formation throughout the neck, chest wall, and mediastinum, findings that may explain the patient¿s left upper extremity swelling.Later that same day, an interventional procedure was performed for removal of the malfunctioning port and retrieval of the intravascular fragment.Under ultrasound and fluoroscopic guidance, the port site was anesthetized and opened.The port reservoir and sutures were removed using sharp and blunt dissection, and imaging confirmed discontinuity between the port reservoir and catheter.The right internal jugular vein was then accessed using a puncture kit, and a wire was advanced under fluoroscopy into the inferior vena cava to facilitate retrieval of the catheter fragment from the right atrium.Attempts to thread a wire through the fractured catheter to obtain left subclavian vein access were unsuccessful due to insufficient catheter length, and the remaining catheter was therefore removed entirely as an intravascular foreign body.Central venography performed during the procedure demonstrated patency of the central portion of the left brachiocephalic vein with occlusion in the mid segment.The incision was closed with sutures, and a sterile dressing was applied.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: M.R.I. LOW-PROFILE IMPLANTABLE PORT,HICKMAN SINGLE-LUMEN, 6.6F
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 24208707
• Report Number: 3006260740-2026-00304
• Device Sequence Number: 5458419
• Product Code: LJT
• UDI-Device Identifier: 00801741025846
• UDI-Public: (01)00801741025846(17)150726(10)REUG0781
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K924250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2015
• Device Catalogue Number: 0603880
• Device Lot Number: REUG0781
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female