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

Catalog Number UNKNOWN PORT

Device Problems Difficult to Flush (1251); Device Appears to Trigger Rejection (1524); Suction Problem (2170)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/09/2015

Event Type  Injury  

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: 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 Description

It was reported through litigation process that sometime post a port placement, the port was allegedly nonfunctional.Furthermore, patient allegedly experienced fibrin sheath formation around the venous track.It was further reported that the port was removed, and new port was implanted.However, 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 device was not returned for evaluation.Medical records were provided and reviewed.The patient underwent removal of old port and placement of new port.Patient with non-functional port who needs chronic central venous access.After the old catheter was examined under fluoroscopy, the pocket was opened, and the old port was removed with blunt and sharp dissection.The catheter was cut and pulled back about 8 to 10 cm and radiocontrast was injected to visualize the venous track of the catheter.A guidewire was inserted and passed down into the inferior vena cava.The catheter was then removed over the guidewire.The venous track of the catheter was stenotic.A long fibrin sheath was present and there was 60-70% stenosis throughout the innominate vein.An angioplasty balloon catheter was passed over the guidewire within the stenosis.A defect was observed in the balloon at the site of the previously identified stenosis.This represented a 60-70% stenosis at that point which resolved completely with balloon inflation.The catheter was passed over the guidewire into the right subclavian vein without difficulty.The tip of the catheter was positioned within the right atrium under fluoroscopic guidance.The new catheter was connected to a bard power port which flushed and aspirated well.The pocket was closed with two layers.Around six months later, patient underwent port implantation procedure.Around three months later, patient presented with neurological symptoms.Eventual workup revealed a superior vena cava stricture and a large azygos vein with some evidence of shunting.She had neurologic symptoms related to flushing the catheter.The transesophageal echocardiogram showed 4-5 cm focal obstruction of the mid portion of the superior vena cava to the opening of the entrance of the cava into the base of the right atrium.The right sided port at the incision was incised and the port-a-cath removed.Fluoroscopic re-examination following removal revealed no retained reminiscent of the catheter, documenting complete removal.Therefore, the investigation is confirmed for the reported suction problem, flushing difficulty and device appears to trigger rejection.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: g3, h6 (method).H11: h1, h6 (result, conclusion).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 Description

It was reported through litigation process that sometime post a port placement, the port was allegedly nonfunctional.It was further reported that the patient allegedly experienced fibrin sheath formation around the venous track.Reportedly, the port was removed, and a new port was implanted.However, the current status of the patient is unknown.

• 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: 19113604
• MDR Text Key: 340252656
• Report Number: 3006260740-2024-01771
• 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: 05/14/2024

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: UNKNOWN PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 50 YR
• Patient Sex: Female