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

Model Number 0602240

Device Problems Fracture (1260); Material Separation (1562); Detachment of Device or Device Component (2907); Migration (4003)

Patient Problems Dyspnea (1816); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/09/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported that post port placement, the device allegedly detached and migrated into the right lower pulmonary artery with thrombus.The patient experienced dyspnea during inflectra administration.The patient's current status was unknown.

Event Description

It was reported that post port placement, the device allegedly detached and migrated into the right lower pulmonary artery with thrombus.The patient experienced dyspnea during inflectra administration.The patient's current status was unknown.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the sample was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported fracture, material separation and migration issue as no objective evidence was provided for review.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.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.The instructions for use states that: contraindications: ¿ this device is contraindicated for catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates of pinch-off.Preventing pinch- off the risk of pinch-off syndrome can be avoided by inserting the catheter via the internal jugular vein (ij).Subclavian insertion of the catheter medial to the border of the first rib may cause catheter pinch-off, which in turn results in occlusion causing port system failure during power injection.If you choose to insert the catheter into the subclavian vein, it should be inserted lateral to the border of the first rib or at the junction with the axillary vein because such insertion will avoid compression of the catheter, which can cause damage and even sever the catheter.The use of image guidance upon insertion is strongly recommended.A radiographic confirmation of catheter insertion should be made to ensure that the catheter is not being pinched.H10: g3, h6(method).H11: h6(device).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.H3 other text : device not returned.

• Brand Name: TITANIUM IMPLANTABLE PORT, BROVIAC SINGLE-LUMEN, 6.6F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12232123
• MDR Text Key: 263883846
• Report Number: 3006260740-2021-02962
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025570
• UDI-Public: (01)00801741025570
• Combination Product (y/n): N
• PMA/PMN Number: K050310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0602240
• Device Catalogue Number: 0602240
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other