MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number DIALYSIS UNKNOWN

Device Problem Product Quality Problem (1506)

Patient Problems Hemorrhage/Bleeding (1888); Loss of consciousness (2418)

Event Date 06/16/2021

Event Type  Injury  

Manufacturer Narrative

Title: three near fatal or fatal complications during implantation of tunnelled hemodialysis catheters source: anaesthesist pp 1-5.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, during surgery of patient #1, it was stated that after the withdrawal of the last dilator the permcath was placed through the introducing device.They tried to aspirate blood however, it was not possible.A contrast agent was applied and a paravascular location of the catheter tip with relevant venous damage was assumed.The patients consciousness and circulation deteriorated, because of that the surgeon had immediate induction of anesthesia and endotracheal intubation was in placed, the cardiac surgeon then performed an emergency sternotomy, open heart massage, a heart lung machine (hlm) was also installed to restore hemodynamic function.The bleeding site in the right brachiocephalic vein was also controlled by the vascular surgeon and the patient was transfused of blood products (11 units of packed erythrocytes, 4 units of fresh frozen plasma, 2 units of thrombocytes and 4g fibrinogen) which helps control the hemorrhagic shock situation.The patient was weaned of the hlm and transferred to the intensive care unit (icu).For cerebral protection a cooling system was installed, and the body temperature was cooled according to institutional standards.The patient could be extubated in the following 24 hours but showed neurological deficits in the form of cortical blindness and a plegic left arm as a result of areas of infarction due to thromboembolism.It was stated that the neurological deficits mentioned was probably caused by the procedure and not specific to the device.The patient had intensive rehabilitation which helped to markedly improve the patient's neurological condition.The rehabilitation was said to be still ongoing.It was stated that prior to insertion there was nothing unusual observe on the catheter.Flushing was also done on the catheter and no problem was observed.The insertion site was treated in accordance to the institutional disinfection standards prior to product placement.The catheter was not replaced/repaired.There were no other products being utilized with the device.There was also no evidence of medtronic pro duct defect related to the event.According to the literature, patient #2, had a long history of renal replacement therapy and repetitive malfunctions of an av fistula which is no longer suitable for hemodialysis.It was stated that after careful mapping of the neck veins it showed an occlusion of the right jugular vein, and so the decision was taken to implant the permcath via the left jugular vein.It was reported that the procedure was planned in a so-called hybrid operating room (a surgical theatre that is equipped with advanced medical imaging devices).During surgery, the left jugular vein was accessed by a vascular surgeon.A terumo wire with angled flexible tip (0.89 mm, 180 cm, radifocus¿ guide wire m, terumo europe n.V., leuven, belgium) was inserted under fluoroscopy and ultrasound guidance and placed in the supracaval vein by a senior staff anesthesiologist.The permcath was subcutaneously tunneled in the left sub clavicular region towards the punction site of the left jugular vein.After dilatation over the guide wire the catheter was advanced to the region of the confluence of the innominate vein and the truncus brachiocephalicus.At this point and at the third dilatation with the introduction device the patient experienced pain and further advancement was immediately stopped.A contrasting agent was applied and showed a leak.No hemorrhagic shock developed because the perforation site was occluded by the introduction device.The patient was anesthetized, and a sternotomy performed by a cardiac surgeon.The perforation site was identified, and the leak was closed by direct suture.The patient was transferred to the icu and was extubated a few hours later.It was said that the patient could be discharged home after a few days with no neurological impairment.After several surgical interventions a functioning arteriovenous fistula was finally established.It was stated that prior to insertion there was nothing unusual observe on the catheter.Flushing was also done on the catheter and no problem was observed.The insertion site was treated in accordance to the institutional disinfection standards prior to product placement.The catheter was not replaced/repaired.There were no other products being utilized with the device.There was also no evidence of medtronic product defect related to the event.

Event Description

According to the literature, during surgery of patient #1, it was stated that after the withdrawal of the last dilator the permcath was placed through the introducing device.They tried to aspirate blood however, it was not possible.A contrast agent was applied and a paravascular location of the catheter tip with relevant venous damage was assumed.The patient¿s consciousness and circulation deteriorated, because of that the surgeon had immediate induction of anesthesia and endotracheal intubation was in placed, the cardiac surgeon then performed an emergency sternotomy, open heart massage, a heart lung machine (hlm) was also installed to restore hemodynamic function.The bleeding site in the right brachiocephalic vein was also controlled by the vascular surgeon and the patient was transfused of blood products (11 units of packed erythrocytes, 4 units of fresh frozen plasma, 2 units of thrombocytes and 4g fibrinogen) which helps control the hemorrhagic shock situation.The patient was weaned of the hlm and transferred to the intensive care unit (icu).For cerebral protection a cooling system was installed, and the body temperature was cooled according to institutional standards.The patient could be extubated in the following 24 hours but showed neurological deficits in the form of cortical blindness and a plegic left arm as a result of areas of infarction due to thromboembolism.It was stated that the neurological deficits mentioned was probably caused by the procedure and not specific to the device.The patient had intensive rehabilitation which helped to markedly improve the patient's neurological condition.The rehabilitation was said to be still ongoing.It was stated that prior to insertion there was nothing unusual observe on the catheter.Flushing was also done on the catheter and no problem was observed.The insertion site was treated in accordance to the institutional disinfection standards prior to product placement.The catheter was not replaced/repaired.There were no other products being utilized with the device.There was also no evidence of product defect related to the event.

Manufacturer Narrative

Correction: b2(removed death), b5, g3, h1(changed to serious injury) medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DIALYSIS UNKNOWN
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 12493526
• MDR Text Key: 272109767
• Report Number: 3009211636-2021-00262
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention