MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM DOME IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0602850
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Migration (4003)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that fifteen years eight months and ten days post port placement, the part of the catheter allegedly fractured and separated.It was further reported that upon x-ray imaging, the catheter allegedly migrated to the heart.Reportedly, the remnant fragment was still inside the patient.The current status of the patient is unknown.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 08/2011).
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 titanium implantable port attached to a groshong catheter in two segments were returned for evaluation.Gross visual, microscopic visual, tactile and functional evaluations were performed on the returned device.The investigation is confirmed for the reported catheter fracture, material separation issues as a complete circumferential break was noted to the distal end of the catheter attached to the port and a complete circumferential break was noted to the proximal end of the distal catheter segment.The edges of the complete circumferential break on the proximal end of the distal catheter segment were noted to be jagged.However, the investigation is inconclusive for the reported migration issue as the exact circumstances at the time of the reported event cannot be verified.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 08/2011).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 fifteen years eight months and ten days post port placement, the part of the catheter allegedly fractured and separated.It was further reported that upon x-ray imaging, catheter allegedly migrated to the heart.Reportedly, the remnant fragment was still inside the patient.The current status of the patient is unknown.

• Brand Name: TITANIUM DOME 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: 15896491
• Report Number: 3006260740-2022-05560
• Device Sequence Number: 6699569
• Product Code: LJT
• UDI-Device Identifier: 00801741025754
• UDI-Public: (01)00801741025754
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K880571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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 Model Number: 0602850
• Device Catalogue Number: 0602850
• Device Lot Number: REQH0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2006
• 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 Age: 67 YR
• Patient Sex: Female