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

Catalog Number	1778000
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Migration (4003)
Health Effect - Clinical Codes	Extravasation (1842); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2011
Type of Reportable Event	Malfunction
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 catheter fracture as no objective evidence was provided for review.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 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) 2011, the patient underwent an implantable port placement procedure via left subclavian vein for chemotherapy of breast cancer.Approximately one month and twelve days later, on (b)(6) 2011, the catheter had allegedly fractured with migration of a fragment.Further, extravasation was reported.Subsequently, the port was removed on (b)(6) 2011.However, the current status of the patient was unknown.
Additional Manufacturer Narrative
H11: additional information was identified in the medical record.Based on the identified information, fractured fragment migrated to the ventricle is determined to be reported as serious injury.Hence, 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 product and lot.Investigation summary: although the sample was not returned for evaluation, medical records were provided and reviewed.Medical alleged that the patient underwent an implantable port placement procedure via left subclavian vein using a power port for delivery of chemotherapy as part of breast cancer treatment and procedure was completed and patient tolerated well.Approximately after one months and twelve days later there was extraluminal leak of contrast into the soft tissue at the upper chest.More importantly, the catheter emanating from the reservoir was fractured.The larger piece of the fractured catheter was located within the right ventricle.Under fluoroscopic guidance the catheter segment was removed.Approximately twelve days later the patient was planned for port removal.A fluoroscopic image was obtained, which showed the intact port with a transected catheter that did seem to be situated in an inferior and posterior position.An incision was made over the old scar, and dissection was carried down to the subcutaneous fat.Upon entering the old cavity, the catheter was seen and was withdrawn.Serous fluid was immediately evacuated once the subcutaneous layer was entered.The fluid was cultured.The procedure was completed and wound was then closed.The wound was dressed.The procedure was tolerated well.Therefore, the investigation is confirmed for the reported catheter fracture, separation and migration, extravasation issue.However, the reported extravasation relationship to the port is unknown.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.Based upon available information, the definitive root cause was unknown.Labeling 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 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: PowerPort 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 22148031
• Report Number: 3006260740-2025-03660
• Device Sequence Number: 15572739
• Product Code: LJT
• UDI-Device Identifier: 00801741026874
• UDI-Public: (01)00801741026874(10)REUJ1243
• 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: 2011
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2026

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: 1778000
• Device Lot Number: REUJ1243
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 09/24/2026
• 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: 47 YR
• Patient Sex: Female