MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. HARD BASE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0604520

Device Problems Fracture (1260); Material Separation (1562); Material Twisted/Bent (2981); Migration (4003)

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

Event Date 03/11/2022

Event Type  Injury  

Event Description

It was reported through the litigation process that sometime post a port placement, the catheter had allegedly fractured.There was no reported patient 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 sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Manufacturer Narrative

Additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 06/2024) 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 the litigation process that one year, seven months, and twenty-five days post a port placement via the right subclavian vein, the device had allegedly malpositioned with the catheter allegedly got coiled in the subclavian region.It was further reported that a retained piece of catheter measuring approximately nine centimeters was found to be extended along the lingular pulmonary arterial branch with the catheter tip got terminated in the distal superior vena cava.Reportedly, the retained portion of the fractured catheter fragment was successfully grasped and removed with a snare device and the port was removed.The current status of the patient is unknown.

Event Description

It was reported through the litigation process that one year, seven months, and twenty-five days post a port placement via the right subclavian vein, the device had allegedly malpositioned with the catheter allegedly got coiled in the subclavian region.It was further reported that a retained piece of catheter measuring approximately nine centimeters was found to be extended along the lingular pulmonary arterial branch with the catheter tip got terminated in the distal superior vena cava.Reportedly, the retained portion of the fractured catheter fragment was successfully grasped and removed with a snare device and the port was removed.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.Medical records were provided and reviewed.The medical record alleges that a new port-a-cath was placed at the right subclavian with the fluoroscopic guidance and partial removal of malfunctioned port-a-cath was performed.The placement procedure was taken place by creating a packet in the right chest wall and cannula was tunneled, from the insertion site into the packet, yes she died later, was placed over the j wire and the j wire and the dilator were removed leaving the sheath in the place.Then further the cannula was advanced without any damage to the sheath, the sheath was then peeled away and under the fluoroscopy, the cannula was pulled back so that the tip would be at the right atrial superior vena cava junction.The port and the cannula were placed in the packet and the insertion site sutured to the chest wall.The port had a good aspiration, and the flow was good without any leakage next to the port on the left side which was addressed with old scar was excised and then dissected down to a port-a-cath and removed the port-a-cath without any event.However, there was a risk of pulling the cannula and breaking the catheter exploring the vein or going under the clavicle, it was better to just leave it and the insertion was closed.The second port became non-functional and was planned to removal.Approximately a year and seven months later, the second port was removed and during the time of removal, it was noted the port was missing a piece and there was a piece of catheter stuck within the lung.After removal the third port was placed in the right chest, and it was functional.After two weeks later, venogram revealed malfunctioning of the right sided port-a-cath catheter coiled to the subcutaneous soft tissue above the right subclavian vessels.There was no evidence of catheter fracture.After a four weeks later, it was suspected that there was a catheter fragment within the pulmonary artery to the left side lower lobe.After a month and twenty days later, the saline was aspirated and it was flushed well confirmed the blood returned in the venogram.Then a month and eighteen days later, a computer tomography of chest with or without contrast revealed that a retained piece of catheter was extending along the lingular pulmonary arterial branch.Approximately two months and fourteen days later, a computer tomography of chest without contrast revealed a retained port catheter fragment within the lingular pulmonary artery.As the right sided port catheter was placed into the internal jugular vein, the catheter tip terminates in the distal superior vena cava.There was a second retained catheter fragment placed through the left subclavian vein extending into the upper aspect of the right atrium.Removal of a fractured fragment was planned on the same day as the patient had history of multiple port catheter placement and retained catheter fragment in the branch of left lower lobe pulmonary artery and secondary placed catheter fragments from the previously placed left subclavian port catheter extending into the right atrium.Fragmented catheter was found in the superior vena cava and within the right atrium, the catheter was directed over the wire through a pulmonary outflow track and into the left lower pulmonary artery.Then the catheter was exchanged over a rosen and wire for 12 french sheaths coaxially placed 9-french sheath was advanced over the wire into the proximal aspect of the left pulmonary artery.The pulmonary angiogram was performed, a bern catheter was used to direct the wire into the linger division of the pulmonary artery adjacent to the catheter fragment, the gooseneck snare catheter was advanced quietly through the sheath and manipulator across the proximal end of the catheter fragment.The fragments were successfully grasped with the snare and pulled into the 9-french sheath under the fluoroscopic guidance.Track position was applied on, the catheter fragment was successfully removed through the sheath and pulled into the surgical field.The catheter was placed in the specimen cup and the 9-french sheath, and the 12-french sheath was subsequently removed.No immediate complication was noted on, the retrieval was successful of port catheter fragment within the lingula division of the left lower low pulmonary artery and the both long retained catheter fragments within the right atrium.As the submitted medical records confirms the evidence of catheter twisting, catheter fracture and separation and catheter migrations, hence the investigation confirms the same respective device malfunctions.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: 06/2024), 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.

• Brand Name: M.R.I. HARD BASE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• 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: 19095292
• MDR Text Key: 340806968
• Report Number: 3006260740-2024-01697
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025853
• UDI-Public: (01)00801741025853
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K873213
• 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,Followup
• Report Date: 05/06/2024

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: 0604520
• Device Lot Number: REDX4987
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/23/2024; 05/03/2024
• Supplement Dates FDA Received: 04/29/2024; 05/09/2024
• 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: 58 YR
• Patient Sex: Male