MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	7707540
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889); Naturally Worn (2988); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one x-port isp implantable port with an attached groshong catheter in two segments were returned for sample evaluation.Gross, visual, microscopic visual, tactile and functional evaluations were performed.A complete compound break was noted on the distal end of the attached catheter and on the proximal end of the distal catheter segment that was elliptical in shape.Two partial compound breaks were noted on the distal catheter segment.The edges of the complete compound break on the distal end of the attached catheter and on the proximal end of the distal catheter segment were noted to be uneven and the surface was noted to be granular in one region and round and smooth in the other region.The edges of the first partial compound break on the distal catheter segment were noted to be uneven.The surface was noted to be round and smooth in both regions.The edges of the second partial compound break on the distal catheter segment were noted to be uneven.The surface was noted to be round and smooth in both regions.The port was patent to both infusion and aspiration without issue.No leaks were observed throughout tests.Therefore, the investigation is confirmed for the reported fracture, material separation and identified wear and deformation issue.However, the investigation is inconclusive for the reported migration issue as no objective evidence to confirm this was provided for review.Although a definitive root cause could not be determined, flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.Such kinking may have physiological, placement, usage or mechanical contributing factors.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, g3, h6 (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.
Event or Problem Description
A patient underwent a port placement procedure using the m.R.I.X-port isp.Post the procedure on (b)(6) 2025, it was reported that the catheter was allegedly ruptured.The main body was removed percutaneously.It was further reported that the ruptured catheter had migrated into the heart and was successfully retrieved using a snare.The current status of the patient was unknown.
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a port placement procedure using the x-port isp m.R.I.For an unknown medical condition.Sometimes post the catheter placement, it was reported that the catheter was allegedly ruptured.The main body was removed percutaneously.It was further reported that the ruptured catheter had migrated into the heart and was successfully retrieved using a snare.The current status of the patient was unknown.

• Brand Name: X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F
• 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: 23189582
• Report Number: 3006260740-2025-07386
• Device Sequence Number: 9026250
• Product Code: LJT
• UDI-Device Identifier: 00801741027499
• UDI-Public: (01)00801741027499
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: 7707540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown