MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM LOW-PROFILE IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0606150
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889); Naturally Worn (2988); Migration (4003)
Health Effect - Clinical Codes	Extravasation (1842); Swelling/ Edema (4577)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Additional 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 device has been returned to the manufacturer for evaluation.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.
Event or Problem Description
It was reported that approximately three years post a port placement, the catheter was removed after it was allegedly found to be fractured.It was further reported that the patient allegedly experienced swelling and saline allegedly leaked.Reportedly, the catheter allegedly migrated and was removed using a snare from the femoral vein.The port and catheter was removed.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one titanium implantable port attached to a groshong catheter in two segments were returned for evaluation.Visual, microscopic, functional and tactile evaluations were performed on the returned device.Multiple kinks were observed to the distal end of the attached catheter.A complete compound break was noted on the distal end of the attached catheter that was elliptical in shape and on the proximal end of the catheter segment and distal end of the catheter segment.The third segment was not returned for evaluation.The edges of the complete compound breaks of the catheter segments were noted to be jagged and the surfaces were noted to be granular in one region and round and smooth in the other region.Splits were noted on the border of both regions.Therefore, the investigation is confirmed for the reported fracture, fluid leak, material separation and the identified naturally worn and deformation issues.However, the investigation is inconclusive for the reported migration issue as the exact circumstance at the time of the event reported was unknown and no evidence to confirm the reported migration was provided for review.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.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 or Problem Description
It was reported that approximately three years post a port placement, the catheter was removed after it was allegedly found to be fractured.It was further reported that the patient allegedly experienced swelling and saline allegedly leaked.Reportedly, the catheter allegedly migrated and was removed using a snare from the femoral vein.The port and catheter was removed.The current status of the patient is unknown.

• Brand Name: TITANIUM LOW-PROFILE IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SL
• Common Device Name: 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: 20693055
• Report Number: 3006260740-2024-06670
• Device Sequence Number: 8584896
• Product Code: LJT
• UDI-Device Identifier: 00801741026058
• UDI-Public: (01)00801741026058
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0606150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown