MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT MRI, 9.6 FR. SILICONE, INTER. KIT W/SUTURE PLUG, S/L; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1859600

Device Problems Difficult to Flush (1251); Fracture (1260); Difficult to Remove (1528); Material Separation (1562); Migration (4003)

Patient Problems Chest Pain (1776); Extravasation (1842); Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/16/2021

Event Type  Injury  

Event Description

It was reported through litigation process that sometime post a port placement, the catheter had allegedly fractured and migrated through heart to pulmonary artery.However, the current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were not provided.Therefore, the investigation is inconclusive for the reported fracture, material separation and migration as no objective evidence was provided for review.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 (expiration date: 05/2021).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.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately six months and twenty-three days post port placement, an x-ray of chest showed left port in place.Around five months and twenty-two days later, patient presented with itching and tenderness over his port which has not been able to flush with extravasation of saline around port site.Around one month and eleven days later, patient presented for follow-up visit.So, the patient underwent port removal procedure.The port was removed with only portion of mediport catheter being present.Patient has been unable to flush his mediport for five or six months.Chest x-ray shows catheter still in mediastinuma and referred to catheter retrieval surgery.Chest x-ray was performed which showed abnormal 15-16 cm segment of radiopaque catheter projects over the central superior mediastinum.This is suspicious for dislodged fractured catheter.Around thirteen days later, chest x-ray after removal demonstrated the distal aspect of the catheter portion of the port likely in the pulmonary arterial circulation.Physician recommended attempts at endovascular retrieval of the dislodged portion of the catheter.Around six days later, patient underwent port catheter removal procedure for retained mediport catheter.Intraoperative findings showed 15 cm catheter straddling the left and right main pulmonary arteries.Unable to successfully retrieve catheter despite multiple different snare devices and access points.Around one day later, patient underwent removal of mediport tubing from bifurcation of pulmonary artery.Intra-operative findings showed catheter fractured and embolized mediport.Physician tried from a superior vena cava approach without success.Around four months and nine days later, a ct of chest, abdomen and pelvis showed 18 cm catheter now present bridging the right and left pulmonary arteries.Left mediport catheter noted stable with the tip overlying the superior vena cava.Tertiary referral for interventional radiology retrieval may be necessary if the patient develops signs of endocarditis or pulmonary emboli.Around six months and three days later, a ct of chest, abdomen and pelvis showed stable appearance of an abandoned pulmonary arterial catheter.Around six months and three days later, a ct of chest, abdomen and pelvis showed pulmonary arterial catheter remains in place and extends across the main pulmonary artery into both pulmonary arteries.Around one month and fifteen days later, an x-ray chest was performed for chest pain showed that abandoned catheter was again identified within the pulmonary arteries splayed across the main pulmonary bifurcation extending into both pulmonary arterial trees.Therefore, the investigation is confirmed for the reported fracture, material separation, migration, difficult to flush and difficult to remove.Furthermore, clinical conditions alleged in the complaint cannot be confirmed.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.H10: d4 (expiration date: 05/2021), g2, g3, h6 (device, method).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.

Event Description

It was reported through litigation process that one year and fourteen days post port placement, the catheter had allegedly fractured and migrated through heart to pulmonary artery and the patient developed chest pain.It was further reported that the port was unable to be flushed and the patient developed extravasation and itching around the port site.Furthermore, the catheter was unable to be successfully retrieved despite multiple different snare devices and access points.Reportedly, the port was removed and fractured catheter fragments remained inside patient body.However, the current status of the patient is unknown.

• Brand Name: POWERPORT MRI, 9.6 FR. SILICONE, INTER. KIT W/SUTURE PLUG, S/L
• 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: 18675097
• MDR Text Key: 334952012
• Report Number: 3006260740-2024-00426
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027208
• UDI-Public: (01)00801741027208
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

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: 1859600
• Device Lot Number: REDZ3200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2020
• 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: 22 YR
• Patient Sex: Male