MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. HARD BASE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0604580
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Dent in Material (2526); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiration date: 12/2024).
Event or Problem Description
It was reported that approximately ten months post port placement, the catheter allegedly fractured and separated.It was further reported that the catheter allegedly migrated into the pulmonary artery.Reportedly the catheter was removed.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 bard mri hard-base implantable port attached to a catheter was returned for evaluation.Gross, microscopic visual, tactile evaluation and functional testing were performed.In addition to the returned physical sample, two medical images and one medical record were provided for review.During sample evaluation, a complete circumferential break was noted on the distal end of the catheter segment which was elliptical in shape.Further, the edges of the complete circumferential break on the distal end of the attached catheter were noted to be uneven and the surface was noted to be granular.However, the medical record review states, approximately ten months post port implantation, a computed tomography (ct) was performed.It revealed that, distal segment material was rupture, being located in the right and left main branches of the pulmonary artery with a total length of around 13 cm.Subsequently, a hemodynamic procedure was performed to remove the device from pulmonary artery.The image review also confirms the same.Therefore, the investigation is confirmed for the reported catheter fracture, migration and material separation and identified dent issues.The characteristics of the break are indicative of pinch-off.A definitive root cause could not be determined based upon the 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.Instruction for use states: "pinch-off prevention: catheters placed percutaneously or through a cutdown, into the subclavian vein, should be inserted at the junction of the outer and middle thirds of the clavicle, lateral to the thoracic outlet.The catheter should not be inserted into the subclavian vein medially, because such placement can lead to compression of the catheter between the first rib and the clavicle, which can cause damage and even sever the catheter.A radiographic confirmation of catheter placement should be made to ensure that the catheter is not being pinched by the first rib and clavicle.1,2" h10: d4 (expiration date: 12/2024), g3, h6 (device).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 ten months post port placement, the catheter allegedly fractured and separated.It was further reported that the catheter allegedly migrated into the pulmonary artery.Reportedly, the catheter was removed.The current status of the patient is unknown.

• Brand Name: M.R.I. HARD BASE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F
• 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: 15741943
• Report Number: 3006260740-2022-04321
• Device Sequence Number: 5838202
• Product Code: LJT
• UDI-Device Identifier: 00801741025877
• UDI-Public: (01)00801741025877
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K873213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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: 0604580
• Device Catalogue Number: 0604580
• Device Lot Number: REEW2068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2020
• 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: 53 YR
• Patient Sex: Female