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

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562); Dent in Material (2526); Migration (4003)

Patient Problem Chest Pain (1776)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, image and photo were provided for review.The investigation of the reported event is currently underway.(expiry date: 04/2024).

Event Description

It was reported that sometime post port placement, during flushing, the catheter was allegedly found to be fractured at the level of the left clavicle and the patient experienced chest pain.It was further reported that the patient underwent surgery to remove the catheter, the catheter was completely fractured and through imaging examination, the tip of the catheter was located near the entrance to the right atrium.The current patient status is unknown.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.Therefore, a device history record review is not required.Investigation summary: one titanium dome implantable port with a groshong catheter was returned for evaluation.Three electronic photos, one medical image and one medical record were provided for review.Visual, microscopic visual, tactile and functional evaluations were performed on the returned device.The investigation is confirmed for the reported catheter fracture, identified material separation and dent in material as two complete circumferential breaks were noted on the catheter.The edges of the complete circumferential break proximal to the port was elliptical in shape with jagged and granular break surface which is consistent with catheter pinch-off issue, but it is uncertain whether the catheter is inserted into the subclavian vein.The distal end of the distal catheter segment was smooth with granular and uniform break surface.Furthermore, two splits were noted on the fractured middle catheter segment.During functional evaluation both the port, attached catheter segment and distal catheter segment were patent to infusion and aspiration without any leak.According to the medical record, the investigation is confirmed for the reported fluid leak, migration, fracture and material separation issue as patient was diagnosed with fractured catheter with its tip located in the cardiac chamber.Intraoperative radioscopy study showed that tip of the catheter was in the upper vena cava/cardiac chamber.Intraoperative findings showed fractured catheter at the level of the left clavicle and the fractured catheter was at the point close to 19 cm.Injection with leakage of content in the subcutaneous tissue was noted and implantable catheter and reservoir removed uneventfully.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 reviewed: the instruction for use states that, "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." ¿signs of pinch-off clinical: ¿ difficulty with blood withdrawal.¿ resistance to infusion of fluids.¿ patient position changes required for infusion of fluids or blood withdrawal radiologic: ¿ grade 1 or 2 distortion on chest x-ray.Pinch-off should be evaluated for degree of severity prior to explantation.Patients indicating any degree of catheter distortion at the clavicle/first rib area should be followed diligently.There are grades of pinch-off that should be recognized with appropriate chest x-ray as follows¿.¿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: d4 (expiry date: 04/2024), g3, h6 (device).H11: h6 (method, result, conclusion).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 Description

It was reported that sometime post port placement, during flushing, the catheter was allegedly found to be fractured at the level of the left clavicle and the patient experienced chest pain.It was further reported that the patient underwent surgery to remove the catheter, the catheter was completely fractured and through imaging examination, the tip of the catheter was located near the entrance to the right atrium.The current patient status is unknown.

• Brand Name: TITANIUM DOME IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• 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: 11075352
• MDR Text Key: 223714343
• Report Number: 3006260740-2020-21115
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

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: REDV2255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 07/03/2021
• Supplement Dates FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17 YR