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

Device Problems Fracture (1260); Difficult to Advance (2920); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/26/2020

Event Type  Injury  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 238599800
• Report Number: 3006260740-2021-00753
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025754
• UDI-Public: (01)00801741025754
• Combination Product (y/n): N
• PMA/PMN Number: K880571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 0602850
• Device Catalogue Number: 0602850
• Device Lot Number: REDT0903
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 06/08/2021
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 70