MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 X-PORT DUO IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, KIT, 9.5F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0607675
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Thrombosis/Thrombus (4440)
Date of Event	03/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the litigation process that sometime post a port placement, the patient allegedly experienced thrombosis.However, the current status of the patent is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.No medical record were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.The definitive root cause could not be determined based upon available information.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.H3 other text : device not returned.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.The medical records allege that, a patient underwent port placement procedure for chemotherapy treatment for breast cancer.Patient had a prior left subclavian ivad.So the doctor decided would place the ivad on the right side.The area was infiltrated with lidocaine and marcaine.Access needle was then used to access the right subclavian vein.A j wire was fed into the superior vena cava under fluoroscopy.Bovie electrocautery was used to dissect down through the subcutaneous tissues to create a pocket for the ivad.The catheter was then advanced from the pocket and then drawn next to the guidewire insertion site.It was then laid in the anterior chest wall and trimmed to length under fluoroscopy.Once the catheter was trimmed to the length and appropriately connected to the ivad reservoir.Once appropriately fixated, the dilator and sheath were advanced over the guidewire into the superior vena cava under fluoroscopy.Once in position, the sheath was slowly peeled away.Each port was then aspirated and flushed and then each port was hep locked.Good blood return was noted.Approximately two years ten month later patient admitted to the hospital as per cardiologist recommendation for right atrial thrombus.Transesophageal echocardiogram was performed which showed normal systolic left ventricle and a large protruding thrombus in the atrial cavity.Patient was continued on heparin drip and switched eliquis to lovenox.Patient was discharged to home with home care on next day.Later three months patient underwent consultation for port removal.Patient developed atrial fibrillation and had an echocardiogram which demonstrated a large protruding thrombus in atrial cavity.Patient was subsequently placed on lovenox and recently transitioned to oral pradaxa.The patient is adamant that the port to be removed.After twenty-six days patient underwent port removal procedure for recent development of right atrial thrombus.The overlying skin infiltrated with lidocaine with epinephrine.A transverse incision was made in the right infraclavicular region.The previously implanted right subclavian dual chamber port was blunt dissected free and removed.The skin edges were reapproximated with vicryl.Patient tolerated the procedure well and discharged home in good condition.A chest x-ray was performed which showed technically successful removal of right subclavian dual chamber port.Therefore, it can be confirmed that the patient experienced thrombosis.However, the relationship to the port is unknown.Furthermore, the clinical condition 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.H10: d4 (expiry date: 12/2023), g2, g3, h6 (method).H11: b3, b5, d4 (medical device lot number), h6 (result).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 the litigation process that two years and ten months post port placement for the treatment for metastatic breast cancer, the patient allegedly developed with thrombosis.It was further reported that the port was removed.The current status of the patent is unknown.
Event or Problem Description
It was reported through the litigation process that two years, 1 month and thirteen days post port placement for the treatment for metastatic breast cancer, the patient allegedly developed with atrial fibrillation.After some time, the patient developed atrial thrombus.It was further reported that the port was removed.The current status of the patent is unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.The medical records allege that, a patient underwent port placement procedure for chemotherapy treatment for breast cancer.Patient had a prior left subclavian ivad.So the doctor decided would place the ivad on the right side.The area was infiltrated with lidocaine and marcaine.Access needle was then used to access the right subclavian vein.A j wire was fed into the superior vena cava under fluoroscopy.Bovie electrocautery was used to dissect down through the subcutaneous tissues to create a pocket for the ivad.The catheter was then advanced from the pocket and then drawn next to the guidewire insertion site.It was then laid in the anterior chest wall and trimmed to length under fluoroscopy.Once the catheter was trimmed to the length and appropriately connected to the ivad reservoir.Once appropriately fixated, the dilator and sheath were advanced over the guidewire into the superior vena cava under fluoroscopy.Once in position, the sheath was slowly peeled away.Each port was then aspirated and flushed and then each port was hep locked.Good blood return was noted.Approximately two years ten month later patient admitted to the hospital as per cardiologist recommendation for right atrial thrombus.Transesophageal echocardiogram was performed which showed normal systolic left ventricle and a large protruding thrombus in the atrial cavity.Patient was continued on heparin drip and switched eliquis to lovenox.Patient was discharged to home with home care on next day.Later three months patient underwent consultation for port removal.Patient developed atrial fibrillation and had an echocardiogram which demonstrated a large protruding thrombus in atrial cavity.Patient was subsequently placed on lovenox and recently transitioned to oral pradaxa.The patient is adamant that the port to be removed.After twenty-six days patient underwent port removal procedure for recent development of right atrial thrombus.The overlying skin infiltrated with lidocaine with epinephrine.A transverse incision was made in the right infraclavicular region.The previously implanted right subclavian dual chamber port was blunt dissected free and removed.The skin edges were reapproximated with vicryl.Patient tolerated the procedure well and discharged home in good condition.A chest x-ray was performed which showed technically successful removal of right subclavian dual chamber port.Post left sided port removal the patient was placed with a right sided port placed tip in svc-atrial junction.Post placement of right sided port the patient presented with dizziness and chest pain with newly detected atrial fibrillation.Therefore, it can be confirmed that the patient experienced thrombosis and atrial fibrillation.However, the relationship to the port is unknown.Furthermore, the clinical condition 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, d4 (medical device expiration date, unique identifier (udi) #), g3, h6 (patient, component).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.

• Brand Name: X-PORT DUO IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, KIT, 9.5F
• 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: 19003214
• Report Number: 3006260740-2024-01362
• Device Sequence Number: 12873083
• Product Code: LJT
• UDI-Device Identifier: 00801741026249
• UDI-Public: (01)00801741026249(17)231231(10)REEN4993
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K034065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2025

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: 12/31/2023
• Device Catalogue Number: 0607675
• Device Lot Number: REEN4993
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 04/29/2024; 06/27/2025
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 05/27/2024; 06/30/2025
• 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: 71 YR
• Patient Sex: Female