MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNKNOWN POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number UNKNOWN POWER PORT

Device Problems Fracture (1260); Detachment of Device or Device Component (2907); Migration (4003)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/02/2022

Event Type  Injury  

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.Medical records were not provided.Therefore, the investigation is inconclusive for the reported fracture, as no objective evidence was provided for review.A definitive root cause could not be determined based upon the 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 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.

Event Description

It was reported through litigation process that sometime post a port placement, the catheter was allegedly fractured.There was no reported patient injury.

Event Description

It was reported through the litigation process that four years, three months, and thirteen days post a port placement via the right internal jugular vein, the portacatheter was allegedly found to be fractured with the hub of the right portacatheter was in the right upper lateral hemithorax, the tip of the proximal portion of the catheter was in the right subclavian region and the reminder of the catheter was in the right side of the heart.It was further reported that the fractured catheter lead was allegedly found to be embolized distally in to the right atrium and right ventricle.Reportedly, the fractured catheter lead was removed endovascularly with loop and snare device and the port was removed.The current status of the patient is unknown.

Manufacturer Narrative

H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately eight months and ten days post port placement, right port-a chest wall catheter was seen, proximal portion of its lead appeared to terminate within the right lower neck.Around three years and six months later, pet/ct scan tumor imaging showed right chest wall port catheter appears to prematurely terminate within the lower right neck, there was a linear density which terminated within right ventricle-this may represent migration of a broken chest catheter.Around one day later, ct of thorax without contrast revealed linear metallic density visualized extending from the right atrium to the posterior aspect of the right ventricle, grossly appears to abut the interventricular septum.Around five days later, chest view showed that there was a fractured right port-a catheter.The hub of the right port-a catheter was in the right upper lateral hemithorax.The tip of the proximal portion of the catheter was in the right subclavian region.The reminder of the catheter was in the right side of the heart.Around one day later, trans vascular retrieval of port-a catheter fracture and so removal was performed.The port-a catheter fracture noted to be in right atrium traversing to right ventricle, removed endovascularly via left femoral vein access with loop and snare.Therefore, the investigation is confirmed for the reported fracture, detachment and migration.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.

• Brand Name: UNKNOWN POWER PORT
• Type of Device: 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: 18570659
• MDR Text Key: 333602029
• Report Number: 3006260740-2024-00160
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN POWER PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASPIRIN
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR