MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 VACCESS CT POWER-INJECTABLE IMPLANTABLE PORT, CHRONOFLEX, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 7480000

Device Problem Migration (4003)

Patient Problems Pain (1994); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/03/2021

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 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.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 the litigation process that sometime post a port placement, the catheter had allegedly migrated.It was further reported that the patient was allegedly diagnosed with thrombosis and internal jugular vein thromboembolism.The current status of the patient is unknown.

Manufacturer Narrative

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.The medical record states that for the treatment of chemotherapy infusion to bladder cancer an right sided port-a-cath was placed.Approximately a month later, the patient had a complaint of neck pain which occurred during in the bit turning the patient felt something pop in the neck region and further the pain was occurred.And computer tomography angiogram was performed off neck shows the right put a catheter tip it's standard up the right internal jugular vein and the tip lies at the level of c3 vertebral body.The study also shows the evidence of thrombosis at the right internal jugular vein extending from the distal tape cranially up to the level of c2, and expansion of opacified proximal right internal jugular vein with stranding adjacent to the thrombosis segment and the opacified segment of the distal internal jugular vein the portion of a bad suicide and enlargement of right internal jugular was also being partially thrombosed.On the same day, an another computer tomography angiogram was performed which showed no pulmonary embolism and the right internal jugular vein thrombosis at the tip of migrated chest port catheter was able to be observed.The patient had also had an acute right internal jugular vein thrombosis at the site of port-a-catheter with the catheter tip that has been migrated up into the internal jugular vein.Hence, the migrated port-a-cath need to be removed.On the next day, x-ray of chest showed the patient's right sided port-a-cath now lies in internal jugular vein, further, the patient underwent cystoscopy and the right retrograde pyelogram and stent placement procedure and at the same day the port was also being removed.As submitted medical record show us the evidence of migrated catheter tip, the investigation is confirmed for they reported migration.Additionally, it can be confirmed that the patient experienced thrombosis, embolism, and pain.However, the relationship to the port is unknown.Furthermore, the clinical condition alleged in the complaint cannot be confirmed.Based upon 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.H3 other text : device not returned.

Event Description

It was reported through the litigation process that one week and six days post a port placement, the tip of the catheter had allegedly migrated up into the internal jugular vein.It was further reported that the patient allegedly experienced neck pain and was diagnosed with thrombosis and internal jugular vein thromboembolism.Reportedly, the port was removed.The current status of the patient is unknown.

• Brand Name: VACCESS CT POWER-INJECTABLE IMPLANTABLE PORT, CHRONOFLEX, 6F
• 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: 18693775
• MDR Text Key: 335187025
• Report Number: 3006260740-2024-00487
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027475
• UDI-Public: (01)00801741027475
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063377
• 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: 03/29/2024

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: 7480000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/12/2024
• 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: 49 YR
• Patient Sex: Female