MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1878001

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Material Separation (1562); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Injury (2348); Embolism/Embolus (4438)

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 (ifu) 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 after port placement, the catheter allegedly dislodged from the port and migrated to the heart.It was further reported that the patient experienced heart attack and underwent surgery.The patient current status is unknown.

Event Description

It was reported that after port placement, the catheter allegedly dislodged from the port and migrated to the heart.It was further reported that the patient experienced heart attack and underwent surgery.The patient current status is unknown.

Manufacturer Narrative

H10: 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 (ifu) 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.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.

Event Description

It was reported through the litigation process, that after port placement, the catheter allegedly break and migrated to the heart.It was further reported that the patient experienced heart attack and underwent surgery.The current status of the patient 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: the sample was not returned for evaluation, however, one electronic photo and medical records were provided for review.The investigation is confirmed for catheter separation and migration, as the photo review identified a catheter fragment that was not attached to the port.Per the medical record review, the patient was examined and supposed to receive further care due to a broken port catheter and a dislodged piece of catheter in the right atrium.Per the medical record review, the computed tomography scan done around august 2018 showed no sign of broken catheter.However, the ct scan was reportedly taken almost a year before the reported date of the port removal.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.H10: d4(expiry date: 06/2021), (device: 1562).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.

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: the sample was not returned for evaluation, one electronic photo and medical records were provided for review.The investigation is confirmed for catheter fracture, separation and migration issues.The photo shows a grainy grayscale image of a port body and two catheter fragments.The shorter catheter fragment appears to be attached to the port body.The poor quality of the photo prohibits a closer examination of the ends of the detached catheter fragment and the distal end of the attached catheter fragment.According to the medical record review, the patient was examined and supposed to receive further care due to a broken port catheter and a dislodged piece of catheter in the right atrium.Furthermore, a computed tomography scan done around august 2018 showed no sign of broken catheter.However, the ct scan was reportedly taken almost a year before the reported date of the port removal.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.The following statements from instructions for use may be useful: "catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates of pinchoff.1,2 port may be placed in lateral subclavian vein based on evaluation by a qualified practitioner." "do not suture catheter to port, port stem, or surrounding tissue.Any damage or constriction of catheter may compromise power injection performance and catheter integrity.Bard access systems, inc.Does not recommend suturing around the catheter as doing so could compress, kink, or damage catheter, including catheter fragmenting and/or fracturing." "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." "do not use a syringe smaller than 10 ml.Flushing occluded catheters with small syringes can create excessive pressures within the port system." "powerport implantable ports are only power injectable when accessed with a powerloc safety infusion set.¿ failure to warm contrast media to body temperature prior to power injection may result in port system failure.¿ failure to ensure patency of the catheter prior to power injection studies may result in port system failure.¿ power injector machine pressure limiting feature may not prevent over pressurization of an occluded catheter.¿ exceeding the maximum flow rate may result in port system failure and/or catheter tip displacement.¿ powerport implantable port indication for power injection of contrast media implies the port¿s ability to withstand the procedure, but it does not imply appropriateness of the procedure for a particular patient nor for a particular infusion set.A suitably trained clinician is responsible for evaluating the health status of a patient as it pertains to a power injection procedure and for evaluating the suitability of any infusion set used to access the port.¿ do not exceed a 300 psi pressure limit setting on the power injection machine, or the maximum recommended flow rate on the powerloc needle, if power injecting through the powerport implantable port.¿ if local pain, swelling or signs of extravasation are noted during power injection, the injection should be stopped immediately." "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 shown in the table at right.3,4" "do not allow accidental device contact with sharp instruments.Mechanical damage may occur.Use only smooth edged, atraumatic clamps or forceps.¿ take care not to perforate, tear, or fracture the catheter during placement.After assembling catheter to port, check assembly for leaks or damage.¿ do not use the catheter if there is any evidence of mechanical damage or leaking.¿ do not bend catheter at sharp angles during implantation.This can compromise catheter patency.¿ carefully follow the connection technique given in these instructions to ensure proper catheter connection and to avoid catheter damage.¿ do not use sutures to secure catheter to the port stem as it could collapse or damage the catheter." "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: 06/2021),g3, h6 (method) h11: d6 (date of implant), g1, h6 (patient, device) 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.

Event Description

It was reported through the litigation process, that after port placement, the catheter allegedly break, migrated to the heart and lodged in right atrium.It was further reported that the patient experienced heart attack and underwent surgery.The current status of the patient is unknown.

• Brand Name: POWERPORT M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032772
• MDR Report Key: 10470589
• MDR Text Key: 204863302
• Report Number: 3006260740-2020-03084
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027253
• UDI-Public: (01)00801741027253
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/12/2022

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: 1878001
• Device Catalogue Number: 1878001
• Device Lot Number: REAY1729
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/31/2020
• Supplement Dates Manufacturer Received: 12/15/2020; 12/18/2020; 12/12/2022
• Supplement Dates FDA Received: 12/16/2020; 01/08/2021; 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female