MAUDE Adverse Event Report: B.BRAUN MEDICAL SAS CELSITE; ACCESS PORT SYSTEM

Model Number 4433750

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 01/14/2019

Event Type  Death  

Manufacturer Narrative

Note: product reference (b)(4) is not cleared for sales in the usa, but its catheter is similar to the product reference (b)(4) cleared under #510k130576.Batch history review: we have checked the manufacturing file of batch nr 36939254 which complies with our specifications and does not present any discrepancy.No other similar complaint has been reported to us on this batch of access ports released in (b)(6) 2018.Investigation results: we did not received the complaint sample for investigation.X-ray picture review: 2 x-ray pictures were sent.But the quality is very poor and makes them inconclusive.Conclusion: the description of the incident is very detailed.No information in this description calls into question the quality of the device itself: neither wrong catheter placement nor haemorrhage can be attributed directly to the device.The investigations carried out by the hospital did not reveal the real cause of the haemorrhage.The hospital considered that this event is part of the published risks related to the implantation of an implantable access port.They agreed to a therapeutic risk and considered that this event was not avoidable.No corrective action is envisaged following this event.

Event Description

(b)(6) 2018: diagnosis of moderately differentiated adenocarcinoma of the pancreas tail with secondary hepatic and peritoneal involvement.Decision in multidisciplinary consultation meeting of a treatment with gemcitabine-based palliative chemotherapy.(b)(6) 2019: consultation in visceral surgery for setting up an implantable access port in order to facilitate infusions.All explanations regarding the surgical techniques, the complications, the benefits-risks of the act and its abstention, have been given to the patient by the surgeon.The surgeon gave her an informed consent forms to be brought back the day of the intervention and to be conveyed to nurse team.Acts programming under local anesthesia, as an outpatient procedure, by right internal jugular on (b)(6) 2019.(b)(6) 2019: the patient is hospitalized in the outpatient surgery unit.14:10, arrives in the operating room 14:53, patient positioned in a supine position, trendelenburg position, the patient is under scope.Skin disinfection with betadine.Local anesthesia with xylocaine 1% without adrenaline, added with sodium bicarbonate.15:12, beginning of the intervention.Under ultrasound guidance, puncture of the right internal jugular vein.Installation of the guide wire, proper operation in superior vena cava is controlled by fluoroscopy.Installation of the definitive catheter using an introducer.Creation of a right pre-thoracic subcutaneous pocket where the catheter is placed after tunneled.Check, with fluoroscopy, that the tip of the catheter is properly positioned in the right atrium.Adaptation of the implantable access port to the catheter and fixing the implantable access port in the pocket which is closed with a continuous suture of safil 3/0.The surgeon tests the access port, no flow back.Smooth passage of the heparinized serum (does not, however, make it possible to check the correct operation).The no flow back seems unusual and questioned for the proper functioning of the implantable chamber and the catheter.The patient looks good at that moment.In these circumstances, the surgeon decides to perform an opacification under fluoroscopic control, which does not show any opacification of cardiac pathways but a diffusion of contrast medium along the mediastinum.The surgeon evokes a wrong path and decides to remove the implantable chamber and the catheter reopening the pocket in order to choose another access, which would be a straight cephalic path.Anesthesia with xylocaïne 1% at the level of the right delto-pectoral sillon region.Incision then dissection step by step to have access to the right cephalic vein.During this dissection, the patient has a sudden discomfort, symptomatic of a hemopneumothorax, probably linked to a venous wound, with persistent cardiac function, that motivates an emergency call of the anesthesia team.Blood pressure at 7, saturation not measurable.When arriving, her hemoglobin was at 12, it decreased to 7 at the hémocue ® control.In order to ease the anesthetic management and resuscitation, the surgeon decides to stop the procedure.The access are closed to ease the resuscitation.A doctor and nurse icu team brings help; installation of an intraosseous catheter in humeral to ease an access because the question of the rupture of the right atrium raises (transthoracic ultrasound scann).The patient is put on oxygen, noradrenaline to raise the blood pressure.The hemoglobin is at 5 at the hémocue ® control.Score glasgow at 9 cardiac echo shows no rupture but blood in the pleura.Chest x-ray shows hemothorax.The patient is positioned laterally, a chest drain is placed.It gives 1 liter of blood; this chest drain is clamped due to low blood pressure.Administration of exacyl ® iv to control bleeding.Transfusion of 8 packed red blood cells and 4 fresh frozen plasma.Temporary improvement of the patient by this time the surgeon contacts the oncologist for advice; no unreasonable attitude; no sternotomy or hemostasis thoracic.More advices from thoracic surgeons are asked.They do not advice either a thoracic surgery but to put a stent if a wound is visible on the scanner.A scanner is done: no leak.Conclusion of the scanner from 2 radiologists: bilateral pulmonary embolism.Abundant right hemopneumothorax.Pneumomediastinum.No active leak of the contrast medium.Infiltration in contact with the confluence of the internal jugular veins, right side subclavian vein at subclavian level.Subcutaneous emphysema with air bubbles that get back in contact with the right internal jugular vein.The chest drain is in place.Requirement of the on-call icu doctor: he advices a reasonable attitude to this critical situation.Limiting and stopping active treatments are discussed.During the evening the patient has dyspnea, lot of blood coming out the chest tube.Agonal breathing.The anesthesiologist sets up a sedation and meets a parent of the patient to explain the situation, what happened, the consequences and answer the questions.21:00, the patient died.

• Brand Name: CELSITE
• Type of Device: ACCESS PORT SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud, 92210 ; FR 92210
• Manufacturer (Section G): B.BRAUN MEDICAL SAS FRANCE; 30 avenue des temps modernes; chasseneuil du poitou, 86360 ; FR 86360
• Manufacturer Contact: catherine boismenu ; 30 avenue des temps modernes; chasseneuil du poitou, 86360 ; FR 86360
• MDR Report Key: 9320966
• MDR Text Key: 166329681
• Report Number: 9612452-2019-00103
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 04038653917594
• UDI-Public: 4038653917594
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2023
• Device Model Number: 4433750
• Device Lot Number: 36939254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2018
• 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): Death
• Patient Age: 63 YR