MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PowerPort isp M.R.I. Implantable Port, ChronoFlex Single-Lumen, 8F; Port & Catheter, Implanted, Subcutaneous, Intravascular

Catalog Number	1808052
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Expulsion (2933)
Health Effect - Clinical Codes	Skin Erosion (2075); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
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.No medical records were provided for review.Therefore, the investigation is inconclusive for the reported catheter fracture as no objective evidence was provided for review.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.Based upon the available information, the definitive root cause is unknown.Labelling 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 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 through the litigation process that sometime post a port placement, the catheter had allegedly fractured.There was no reported patient injury.
Event or Problem Description
It was reported through the litigation process that, on (b)(6)2022, a patient underwent port placement via the right internal jugular vein for an unknown medical condition.Approximately one year, three months and twenty four days later, on (b)(6)2023, the catheter had allegedly fractured with discontinuation of remaining catheter.Subsequently, the port was removed on (b)(6)2023.During the removal procedure, the skin over the chest port was noted to be thinned.However, the current status of the patient remains unknown.
Additional Manufacturer Narrative
H11: additional information was identified in the medical record.Based on the identified information the file was reassessed for reportability and determined to be reportable as serious injury.Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this lot.Investigation summary: the physical device was not returned for evaluation.Medical records were provided for review.Medical record alleges that, on (b)(6)2022, the patient underwent an implantable port placement procedure via right internal jugular vein using a powerport.One year three months and twenty-four days later a chest x ray was performed and reported catheter fracture and discontinuation with the remaining catheter.The next day, port removal and fragment retrieval were planned.Using ultrasound-guided right femoral vein access, the fractured chest port catheter was successfully snared and removed through a vascular sheath without complications.After catheter retrieval, the existing right chest port was assessed and noted to have thinned skin over the port reservoir, raising concern that continued use could lead to skin breakdown and port exposure.The investigation is confirmed for the reported catheter fracture, material separation, expulsion.Furthermore, the clinical condition erosion alleged in the complaint can 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.B1, b3, b5, g3, h1, h6 (patient, device, component, 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: PowerPort isp M.R.I. Implantable Port, ChronoFlex Single-Lumen, 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 22468733
• Report Number: 3006260740-2025-04662
• Device Sequence Number: 12785892
• Product Code: LJT
• UDI-Device Identifier: 00801741027024
• UDI-Public: (01)00801741027024(17)230228(10)REFW3080
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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 Expiration Date: 02/28/2023
• Device Catalogue Number: 1808052
• Device Lot Number: REFW3080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 09/28/2026
• 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: 38 YR
• Patient Sex: Female