MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0602660

Device Problems Fracture (1260); Material Separation (1562); Suction Problem (2170); Dent in Material (2526); Deformation Due to Compressive Stress (2889); Migration (4003)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/07/2023

Event Type  Injury  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records will 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.H10: d4 (expiry date: 06/2026).H11: section a through f: the information provide 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 sometimes, post port placement for cancer treatment, the port allegedly compressed, eroded, and pinched off.It was further reported that the physicians were unable to draw back from the port during the infusion.Furthermore, an x-ray review showed that a large piece of the catheter measuring over five centimeters had broken away and lodged in the patient's heart.Reportedly, the patient underwent an emergency heart catheterization to retrieve the catheter segment from the heart and will undergo surgery to remove those portions of the device that remain implanted; however, the current status of the patent 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 not provided.Therefore, the investigation is inconclusive for the reported failure 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 (expiry date: 06/2026), g3.H11: section a through f: the information provide 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 ten months and twenty eight days post port placement the physicians were unable to draw back from the port during the infusion.It was further reported that an x-ray review showed that a large piece of the catheter measuring over five centimeters had broken away and lodged in the patient's heart.Reportedly, the patient underwent an emergency heart catheterization to retrieve the catheter segment from the heart and will undergo surgery to remove those portions of the device that remain implanted; however, the current status of the patent 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 patient shoulder was prepped and draped in the usual sterile manner.Under fluoroscopic guidance, a bard mri implantable port was placed in a patient after being diagnosed with breast cancer.Postoperative chest x-ray showed adequate placement.Ten months and twenty-eight days post port placement, the blood was allegedly unable to be withdrawn from the patient¿s port.X-ray of port with contrast injection was performed which showed only a small portion of the left subclavian port.It was further reported that there was allegedly a broken left subclavian port large segment of the catheter measuring over five centimeters within the heart under x-ray examination.On the same day, removal of migrated port catheter segment was performed in the heart for a patient noted to have complication of cardiovascular infusion catheter and with unspecified complication.Through the right femoral vein access, a 20 mm snare was advanced through a jr4 guide catheter.The retained portion of the port catheter segment was easily captured and withdrawn with a snare device through the venous access site.The sheath was removed, and pressure was utilized to gain hemostasis, and the patient was discharged to recovery room in stable condition.Therefore, the investigation is confirmed for the reported fracture, material separation, migration and suction issue.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: 06/2026).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 ten months and twenty-eight days post a port placement, the blood was allegedly unable to be withdrawn from the patient's port.It was further reported that a large segment of the port catheter measuring over five centimeters was allegedly broken and separated from the port under x-ray examination.It was also reported that the fractured catheter segment had allegedly migrated within the patient's heart.Furthermore, patient allegedly experienced extreme pain.Reportedly, the retained portion of the port catheter segment was easily captured and withdrawn with a snare device through the venous access site.The current status of the patient is unknown.

• Brand Name: M.R.I. IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F
• 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: 17648960
• MDR Text Key: 322242301
• Report Number: 3006260740-2023-03790
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025655
• UDI-Public: (01)00801741025655
• 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,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2024

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: 0602660
• Device Lot Number: REFX2026
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 11/30/2023; 04/18/2024
• Supplement Dates FDA Received: 12/07/2023; 04/24/2024
• 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: 48 YR
• Patient Sex: Female