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

Catalog Number	1808560
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Arrhythmia (1721); Chest Pain (1776); Dyspnea (1816); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the litigation process that, on (b)(6) , 2020, a patient underwent left port placement for chemotherapy delivery.Approximately two years, nine months and three days later, on(b)(6) , 2023, the patient was diagnosed with chest pain and pulmonary embolism.Further, approximately three days later, on (b)(6) , 2023, the patient experienced shortness of breath and was diagnosed with coronary artery disease.Approximately four months and thirteen days later, on (b)(6) , 2023, the patient again presented with the chest pain and a subsequent electrocardiogram revealed occasional premature ventricular complexes.Additionally, it was also reported that the patient was diagnosed with thrombosis.However, the current status of the patient remains unknown.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H6 (patient, result, conclusion) 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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.\ \ investigation summary: although the physical device was not returned for evaluation, medical records were provided for review.Medical record alleges that,the patient underwent implantation of a powerport isp m.R.I.Implantable port on the left side.Approximately two years and nine months later, the patient presented with chest pain, shortness of breath, and coronary artery disease.Approximately four months later, the patient again presented with chest pain radiating to the left arm, and ecg demonstrated sinus rhythm with occasional premature ventricular complexes (pvcs).A review of sterilization records, endotoxin testing results, and bioburden data was conducted in accordance with applicable quality system and regulatory requirements, and no nonconformances or anomalies were identified.The investigation is inconclusive for the reported thrombosis as no objective evidence was provided for review.Furthermore, the clinical conditions 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, d4 (unique identifier (udi) #), g3, h6 (method, result, conclusion).\ \ 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.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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
It was reported through the litigation process that, on (b)(6), 2020, a patient underwent left port placement for chemotherapy delivery.Approximately two years, nine months and three days later, on (b)(6), 2023, the patient was diagnosed with chest pain and pulmonary embolism.Further, approximately three days later, on (b)(6), 2023, the patient experienced shortness of breath and was diagnosed with coronary artery disease.Approximately four months and thirteen days later, on (b)(6), 2023, the patient again presented with the chest pain and a subsequent electrocardiogram revealed occasional premature ventricular complexes.Additionally, it was also reported that the patient was diagnosed with thrombosis.However, the current status of the patient remains unknown.
Event or Problem Description
It was reported through the litigation process that, on (b)(6) 2020, a patient underwent left port placement for chemotherapy delivery.Approximately two years, nine months and three days later, on (b)(6)2023, the patient was diagnosed with chest pain and pulmonary embolism.Further, approximately three days later, on (b)(6) 2023, the patient experienced shortness of breath and was diagnosed with coronary artery disease.Approximately four months and thirteen days later, on (b)(6) 2023, the patient again presented with the chest pain and a subsequent electrocardiogram revealed occasional premature ventricular complexes.Additionally, it was also reported that the patient was diagnosed with thrombosis.However, the current status of the patient remains unknown.

• Brand Name: PowerPort isp M.R.I. Implantable Port, Groshong 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: 25229493
• Report Number: 3006260740-2026-03497
• Device Sequence Number: 10183920
• Product Code: LJT
• UDI-Device Identifier: 00801741027116
• UDI-Public: (01)00801741027116(11)190621(17)220131(10)REDS1463
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2026

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: 01/31/2022
• Device Catalogue Number: 1808560
• Device Lot Number: REDS1463
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 04/27/2026; 07/29/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 05/21/2026; 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Atorvastatin; Carvedilol; Ezetimibe; Lisinopril
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 182 LB