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

Model Number	0655870
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Expiration date: 08/2025.Device pending return.
Event or Problem Description
It was reported that one month and eight days post port placement, the tear allegedly occurred at about 50 cm and was identified under fluoroscopy using a contrast agent.It was further reported that the patient allegedly experienced arm pain and warm at first due to tear.Reportedly, the port system was removed.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one x-port mri isp attached to a catheter in two segments was returned for evaluation.Functional, gross visual, tactile, and microscopic visual evaluations were performed.In addition to the returned physical sample, one electronic image was provided for review.The image show an arm with possible contrast around the humerus area and a tear in the tubing could over time if the tubing crosses a point of flexion.Based on the image review the reported event cannot be confirmed.However, the whole investigation is confirmed for the reported fracture issue, as a complete circumferential break was noted at the distal end of the catheter attached and a partial circumferential break was noted on the proximal end of the distal catheter segment.Upon infusion, a leak was observed from the partial circumferential break on the catheter.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: 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.
Event or Problem Description
It was reported that one month and eight days post port placement, the tear allegedly occurred at about fifty centimeter and was identified under fluoroscopy using a contrast agent.It was further reported that, the patient allegedly experienced arm pain and warm at first due to tear.Reportedly, the port system was removed.There was no reported patient injury.

• 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: 16485832
• Report Number: 3006260740-2023-00677
• Device Sequence Number: 20544006
• Product Code: LJT
• UDI-Device Identifier: 00801741026331
• UDI-Public: (01)00801741026331
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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
• Operator of Device: Health Professional
• Device Model Number: 0655870
• Device Catalogue Number: 0655870
• Device Lot Number: REFW5086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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
• Patient Age: 37 YR
• Patient Sex: Unknown