MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 M.R.I Implantable Port, Hickman Single-Lumen, 9.6F; Port & Catheter, Implanted, Subcutaneous, Intravascular

Catalog Number	0602680
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260); Difficult to Remove (1528); Material Separation (1562); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that twenty two years, two months and twenty three days old female patient underwent a port placement procedure using a m.R.I port for the treatment of stage ii hodgkin¿s lymphoma.On (b)(6) 2026, during the heparinization procedure, the patient developed severe pain.A chest x ray revealed a port o cath catheter fracture with embolization into the right atrium.The patient was subsequently scheduled for percutaneous removal of the intravascular foreign body and removal of the right subclavian vein port o cath via open anterior thoracic surgery.The removal procedure was reported to be very difficult.An attempt to capture the fractured catheter using a 6 fr multilobed snare was unsuccessful.The catheter was subsequently captured and removed using a 6 fr single-lobed snare catheter.Current status of the patient is reported to be stable.
Event or Problem Description
It was reported that twenty two years, two months and twenty three days old female patient underwent a port placement procedure using a m.R.I port for the treatment of stage ii hodgkin¿s lymphoma.On (b)(6)2026, during the heparinization procedure, the patient developed severe pain.A chest x ray revealed a port o cath catheter fracture with embolization into the right atrium.The patient was subsequently scheduled for percutaneous removal of the intravascular foreign body and removal of the right subclavian vein port o cath via open anterior thoracic surgery.The removal procedure was reported to be very difficult.An attempt to capture the fractured catheter using a 6 fr multilobed snare was unsuccessful.The catheter was subsequently captured and removed using a 6 fr single lobed snare catheter.Current status of the patient is reported to be stable.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the sample was not returned for evaluation.Two chest x ray images and medical records were provided for review.In image review, the pa chest shows the port in the right subclavian region with a short segment of attached proximal catheter; the distal segment has migrated to the right heart.The lateral film also depicts the migrated distal segment of catheter in the right heart.In medical record states that sometime after the port placement procedure, during the heparinization procedure, the patient developed severe pain.A chest x ray revealed a port o cath catheter fracture with embolization into the right atrium.The patient was subsequently scheduled for percutaneous removal of the intravascular foreign body and removal of the right subclavian vein port o cath via open anterior thoracic surgery.The removal procedure was reported to be very difficult.An attempt to capture the fractured catheter using a multilobed snare was unsuccessful.The catheter was subsequently captured and removed using a single lobed snare catheter.Therefore, the investigation is confirmed for the reported catheter fracture, material separation, and migration, difficult to remove and entrapment of device issues.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, d4 (unique identifier (udi) #), g3, h6 (patient, device, component, method, result, conclusion).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 Implantable Port, Hickman Single-Lumen, 9.6F
• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50467574
• Report Number: 3006260740-2026-06226
• Device Sequence Number: 10063133
• Product Code: LJT
• UDI-Device Identifier: 00801741025679
• UDI-Public: (01)00801741025679(11)240607(17)270331(10)REJN3098
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K873213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0602680
• Device Lot Number: REJN3098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2024
• 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: 22 YR
• Patient Sex: Female