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

Model Number 1878000

Device Problems Fracture (1260); Material Separation (1562); Migration (4003)

Patient Problems Pulmonary Embolism (1498); Cardiac Perforation (2513)

Event Date 05/30/2019

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: 01/2021).

Event Description

It was reported that post port device implant, the catheter was allegedly fractured and the patient underwent surgery to remove the fractured catheter from the right ventricle.It was further reported that the device embolized the right atrium.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: this is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: the sample was not returned for evaluation, a medical record review was performed.The investigation is confirmed for the reported catheter fracture, separation, and embolism, as the medical record review identified catheter tubing lodged within the coronary sinus extending into the right atrium.According to the medical record review, all known catheter fragments were retrieved and the retrieval of the fragments was uneventful.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.Instructions for use reviewed.The instructions 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." ¿warning: do not power inject through a port system that exhibits signs of clavicle-first rib compression or pinch-off, as it may result in port system failure.¿ ¿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: b5, d4 (expiry date: 01/2021).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.

Event Description

It was reported through the litigation process that post port device implant, the catheter was allegedly fractured and the patient underwent surgery to remove the fractured catheter from the right ventricle.It was further reported that the device embolized the right atrium.The current status of the patient is unknown.

• Brand Name: POWERPORT M.R.I. IMPLANTABLE 8F GROSHONG SINGLE-LUMEN
• 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: 11672191
• MDR Text Key: 245599987
• Report Number: 3006260740-2021-01340
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027246
• UDI-Public: (01)00801741027246
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1878000
• Device Catalogue Number: 1878000
• Device Lot Number: REBX2043
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 70 YR