MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 X-PORT LOW-PROFILE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0655870
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Material Puncture/Hole (1504); Suction Problem (2170); Difficult to Advance (2920)
Health Effect - Clinical Codes	Extravasation (1842); Unspecified Infection (1930); Thrombosis/Thrombus (4440)
Date of Event	12/18/2003
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through litigation process that sometime later port placement procedure; the catheter allegedly had fractured, and the patient had also allegedly developed with infection and thrombosis.However, the current status of the patient is unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: 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.
Event or Problem Description
It was reported through the litigation process that, on (b)(6) 2003, a patient underwent port placement via the right basilic vein for parenteral nutrition.During the procedure, the catheter was difficult to advance.Additionally, it was reported that the catheter could not be aspirated and contrast coursing around the catheter tubing near the entry point of the subclavian vein.Further, the catheter allegedly had a hole.Subsequently, on (b)(6) 2013, the port was removed and new port was implanted on the same day.During the removal, a leak was identified at the port site near the sternoclavicular junction.However, the current status of the patient remains unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: although the physical device was not returned for evaluation, medical records was provided for review.Medical record alleges that, a right arm port was implanted (catalog: 0655870 and lot: 22hn639).Attempt was then made to traverse the catheter for the port into the superior vena cava over the wire.Imagination revealed stenosis in the right basilic vein along the course of the catheter.Despite aggressive pushing, the catheter would not advance across the stenosis.Therefore, the lesion was successfully treated with angioplasty using a 5 × 2 balloon.After improvement of luminal caliber post angioplasty, the catheter was then readvanced successfully across the stenosis into the superior vena cava.The catheter was appropriately flushed and left accessed as requested.On the same day, ir angio abdominal aorta was performed which revealed that the catheter could not aspirate.Injection of contrast demonstrates contrast coursing around the catheter tubing near the entry point of the subclavian vein and non functioning right chest port with apparent hole in the catheter.This should not be used and should be replaced.Nine years, seven months and one day later, as the port was nonfunctioning, the implanted port was removed.A large bore needle was placed in the left subclavian vein on the first pass but could not thread a wire through it to the thrombus.Then moved to the right side where the port was injected with the saline and a contrast was injected under the fluoroscopy which identified a leak at the port site near the sternoclavicular junction.Then the physician decided to open it up just proximally to its insertion site on the skin and then thread a wire through that portion of the catheter into the right heart.The port was within the svc and right atrium was removed.Once pulled it back, the wire was accessed into the right atrium.Then dilator and sheath were kept over the wire, removed the wire and the dilator through the catheter through the sheath in its entirety.Then went over the old port site, made an incision over it, and removed the distal port and the remaining catheter.Therefore, the investigation is confirmed for the reported difficult to advance issue, catheter fracture, catheter puncture or hole, fluid leak and suction issues.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.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.B3, b5, g3, h6 (patient, device, method, result) section a through f: the information provided 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: X-PORT LOW-PROFILE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 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: 21628764
• Report Number: 3006260740-2025-01558
• Device Sequence Number: 21064175
• Product Code: LJT
• UDI-Device Identifier: 00801741026331
• UDI-Public: (01)00801741026331
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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 Catalogue Number: 0655870
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/27/2026
• 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: 39 YR
• Patient Sex: Female