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

Catalog Number UNK PORT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 09/12/2023

Event Type  Injury  

Event Description

It was reported through the litigation process that one week and five days post port placement, the patient allegedly developed hematoma.The current status of the patient was unknown.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H11: 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 Description

It was reported through the litigation process that one week and five days post a port placement in the left anterior superior chest wall via the left internal jugular vein, the patient allegedly developed hematoma.The current status of the patient is unknown.

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.Medical records were provided and reviewed.Approximately ten years post port placement, replacement of subcutaneous injection right port was planned.An incision was made, the old port was exposed and removed from the pocket.The catheter was cut and a guidewire was passed through this into the central venous system, and the old catheter was removed.This was an end hole type catheter and appears to be intact.A peel away catheter was passed over the guidewire.The pressure injectable groshong type catheter was passed through the peel-away positioning the tip at the inlet to the heart.The peel-away was removed.A locking stitch was passed through the catheter and tied down to the soft tissue.The catheter was cut to length.It was affixed to a large pressure injectable mri type subcutaneous injection port.The locking collar was clicked in place.The pocket was dissected to accommodate the new port.The port was positioned so the catheter has a smooth curve.The port was sutured within the pocket to prevent it from flipping.The exposed subcutaneous portion of the catheter was buried.Port function was checked using a huber needle and was found to aspirate and inject quite appropriately.The catheter was flushed with saline and the huber was removed.The pocket was then lightly irrigated.Around two years and three months later, the patient was diagnosed with pulmonary embolism.Around two months later, right chest port was in place, but the catheter was broken with the distal catheter fragment coiled in the location of the right atrium.Dislodged catheter was in right atrium.The patient experienced palpitations-secondary to right atrial foreign body/catheter.Around two days later, electrocardiogram indicated that elevated cardiac enzyme back in non-st elevation myocardial infarction, could be related to damage from the dislodged catheter.The next day, after successfully identifying a patent right internal jugular vein, a combination of recovery snare system was advanced to the level of the dislodged catheter tip within the right ventricle.The catheter was captured and ensheathed under fluoroscopic guidance and the catheter was retrieved successfully.Post catheter fragment removal fluoroscopy demonstrated no residual catheter fragment within the cardiac chambers or chest vascularity.Using blunt dissection, a port pocket was created on the right anterior chest wall.The existing port was removed in its entirety with residual catheter fragment attached to the port and fluoroscopy demonstrated no residual subcutaneous chest port fragment.A tunnel was created in the right anterior superior chest wall.The port was affixed to 6 french tubing which was passed through the tunnel and into the internal jugular vein.Under fluoroscopic guidance, the tip was positioned within the superior vena cava.The port was heparinized and flushed well.The patient tolerated the procedure well without immediate complications.Successful placement of new single lumen 6 french port in the right anterior chest wall with catheter via right internal jugular vein approach was performed.The next day, the patient had episode of atypical chest pain, elevated cardiac enzymes and serial troponin levels with a port-a-cath segment in the right atrium, status post removal.The patient had recurrent palpitations likely related to right atrial foreign body.Around ten months later, the patient had concerns with the port-a-cath that was placed in her right subclavian and this may have led to an infection.Around one month later, x ray chest revealed that repositioning of the port catheter with the tip now overlying the superior vena cava when compared to prior exam.Around two years and nine months later, the patient complained of infected subclavian port with abscess.Around two days later, the patient today reported of continued pain to the right chest wall surrounding the port-a-cath however reported pain was a little bit more tolerable today.Patient was currently pending for possible removal of port-a-cath.A small port incision was created, the port connected to the catheter were successfully explanted with pre and post fluoroscopic images demonstrating no residual intrathoracic catheter fragment.The patient tolerated the procedure well without immediate complication.Successful removal of right anterior chest wall port.Catheter/port sent for cultures.Around twenty-four days later, after successfully identifying a patent left internal jugular vein, using blunt dissection, a port pocket was created on the left anterior chest wall.An approximately 4 cm long tunnel was created in the left anterior superior chest wall.The port was affixed to 6 french 24 cm tubing which was passed through the tunnel, and into the internal jugular vein.Under fluoroscopic guidance, the tip was positioned within the superior vena cava.The port was heparinized and flushed well.Port incision was closed.The patient tolerated the procedure well without immediate complication.Around twelve days later, the patient appeared to have a hematoma near left chemo port.There was no clear evidence of infection at this point.Around two months later, the patient presented with hematoma over the port-a-cath site, appeared to be improving.Per the submitted medical record review, it was confirmed that the patient had hematoma.However, the relationship between the port and the alleged adverse event is unknown, and there is no device malfunction reported.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: b5, g3, h6 (method) h11: h6 (result, conclusion) 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.

• Brand Name: UNKNOWN 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: 19034574
• MDR Text Key: 339278172
• Report Number: 3006260740-2024-01432
• 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,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/07/2024
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female