MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 7F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0603870CE

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Difficult to Remove (1528); Material Separation (1562); Migration (4003)

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

Event Date 03/22/2024

Event Type  Injury  

Event Description

It was reported that one month one day post a port placement, the port allegedly leaked.It was further reported that the catheter was allegedly found to be in the heart plane upon x-ray imaging.It was also reported that the catheter was allegedly unable to removed either through jugular or femoral veins and upon ct examination the catheter was allegedly found in the right and the left pulmonary artery.Reportedly, the port was removed and only the minor part of the catheter is fixed by the sleeve and the remaining part was allegedly torn away and migrated.The current status of the patient is unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products is identified in d2 and g4.H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.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.H3 other text : device pending return.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products is identified in d2 and g4.Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported fluid leak, catheter fracture, material separation, migration and difficulty in removal issues as no objective evidence was provided for review.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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 that one month and one day post a port placement, the port allegedly leaked.It was further reported that the catheter was allegedly found to be in the heart plane upon x-ray imaging.It was also reported that the catheter was allegedly unable to be removed either through jugular or femoral veins and upon computed tomographic examination, the catheter was allegedly found in the right and the left pulmonary artery.Reportedly, the port was removed and only the minor part of the catheter was fixed by the sleeve and the remaining part was allegedly torn away and migrated.The current status of the patient is unknown.

• Brand Name: M.R.I. LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 7F
• 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: 19183698
• MDR Text Key: 341064909
• Report Number: 3006260740-2024-01922
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K924250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2024

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: 0603870CE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/27/2024
• 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