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
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.However, an image was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 07/2026) 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.
Event or Problem Description
It was reported that twenty-six days post a port placement, the catheter allegedly separated.It was further reported that the distal segment of the catheter was allegedly found to be lodged inside the patient's left pulmonary artery.Reportedly, the catheter was removed, but the distal segment of the catheter allegedly remained inside the patient's body.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one groshong catheter in two segments were returned for evaluation and one image was provided for review.Visual, microscopic, functional and tactile evaluations were performed on the returned device.A complete compound break was noted on the distal end of the attached catheter and on both ends of the distal catheter segment.The edges of the complete compound break on the distal end of the attached catheter, on the distal end of the distal catheter segment and on the proximal end of the distal catheter segment were noted to be uneven and the surface was noted to be finely granular throughout.The chest x-ray shows two segments in which the short segment was noted in the right sub-clavicular region and the longer segment is seen in the region of the left pulmonary artery.Therefore, the investigation is confirmed for the reported material separation, migration and the identified fracture issues.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6 (device) h11: d4 (unique identifier (udi) #), h6 (method, result, conclusion) 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 twenty-six days post a port placement, the catheter allegedly separated.It was further reported that the distal segment of the catheter was allegedly found to be lodged inside the patient's left pulmonary artery.Reportedly, the catheter was removed, but the distal segment of the catheter allegedly remained inside the patient's body.However, the current status of the patient is unknown.

• Brand Name: M.R.I. HARD BASE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• 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: 20457144
• Report Number: 3006260740-2024-05935
• Device Sequence Number: 20782042
• Product Code: LJT
• UDI-Device Identifier: 00801741025853
• UDI-Public: (01)00801741025853(11)230303(17)260731(10)REGZ2583
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K873213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 01/02/2025

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 0604520
• Device Lot Number: REGZ2583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 43 YR
• Patient Sex: Male