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

Catalog Number	1708560
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Expulsion (2933); Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Skin Erosion (2075)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: 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 fracture, erosion and infection 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.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f - the information provided by bd represents all of 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 litigation process that sometime later port placement, the catheter was allegedly fractured.It was further reported that the port allegedly eroded, and the patient allegedly developed with infection.However, the current status of the patient was unknown.
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, medical record was provided for review.Medical record alleges that, the patient underwent an implantable port placement procedure using a powerport for chemotherapy delivery as part of breast cancer treatment.About one month and twenty one days later, the patient was diagnosed with a broken catheter.The patient was planned for port removal.During removal procedure, the catheter was noted to be severed at the neck.The neck incision was reopened and explored, and the catheter was not seen.The patient was then moved to the x ray table and re prepped in the groins and left chest.Ultrasound guided access was obtained in the left groin.Under fluoroscopic guidance, a reverse curve catheter and snare were used to pull the catheter that was in the right atrium and ventricle.The snare was used to grasp the end of the catheter, and it was removed along with the sheath.Therefore, the investigation is confirmed for the reported catheter fracture, material separation and migration.The investigation is inconclusive for the reported expulsion or port/skin erosion as no evidence was found in the provided medical report.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 (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.
Event or Problem Description
It was reported through litigation process that on (b)(6), 2023, a patient underwent port placement via the left internal jugular vein for chemotherapy related to breast cancer.Approximately, one month and twenty one days later, on (b)(6), 2023, the catheter had allegedly fractured with migration of a fragment to right atrium and ventricle.It was further reported that the port had eroded and the patient was diagnosed with an unspecified infection.Subsequently, the port was removed on the same day.However, the current status of the patient was unknown.

• Brand Name: POWERPORT ISP IMPLANTABLE PORT, CHRONOFLEX 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: 21961868
• Report Number: 3006260740-2025-02823
• Device Sequence Number: 7265270
• Product Code: LJT
• UDI-Device Identifier: 00801741026706
• UDI-Public: (01)00801741026706(17)251231(10)REGZ3113
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K081311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/09/2026

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 Expiration Date: 12/31/2025
• Device Catalogue Number: 1708560
• Device Lot Number: REGZ3113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 04/22/2026
• 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: 65 YR
• Patient Sex: Female