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

Model Number	0602850
Medical Device Problem Codes	Fracture (1260); Difficult to Advance (2920); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/26/2020
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 device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 10/2023).
Event or Problem Description
It was reported through the litigation process that an implantable port was placed in a patient, the reason for placement was not given.Approximately 3 months after port placement, the device allegedly fractured and migrated to the patient's right ventricle.It was further reported that patient underwent heart surgery to remove the fractured catheter.The current status of the patient is unknown.
Event or Problem Description
It was reported through the litigation process that an implantable port was placed in a patient, the reason for placement was not given.Approximately three months after port placement, the device allegedly fractured and migrated to the patient's right ventricle.It was further reported that patient underwent heart surgery to remove the fractured catheter.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the third complaint reported for this lot number.Therefore, a device history record review was performed and the lot met all release criteria.Investigation summary: the sample was not returned for evaluation.One medical record was provided for review.The investigation is confirmed for catheter fracture, migration and difficult to insert wire as during deployment, after several attempts, it was able to pass a wire without any resistance into the superior vena cava right atrial junction.Post filter deployment, chest x-ray revealed that there was no evidence of pneumothorax or hematoma.Approximately three months later, the patient pretested for port removal.The port catheter fractured and ended up in the right ventricle and was retrieved successfully by interventional radiology.Subsequently under the guidance of fluoroscope, complete removal of the proximal fragment attached to port was accomplished.There was no bleeding.The port and complete fragment attached to port was removed.A 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.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 not returned.

• Brand Name: TITANIUM DOME IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• Common Device Name: PORT & CATHETER, IMPLANED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11444198
• Report Number: 3006260740-2021-00753
• Device Sequence Number: 19707299
• Product Code: LJT
• UDI-Device Identifier: 00801741025754
• UDI-Public: (01)00801741025754
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K880571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: REDT0903
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 70