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

Model Number DIALYSIS UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Hemothorax (1896)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

Title: hemothorax caused by replacement of hemodialysis catheter: a case report.Source: hemodialysis international 2016; 20:e7¿e10.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study, it was reported that a long-term dialysis catheter accidentally inserted into the mediastinum via the right jugular vein in a hemodialysis patient.The patient had cough and dyspnea of 3 days duration and had a history of elevated blood creatinine for one year.Upon hospital admission (day 1), anti-infection and diuretic therapies were administered for 3 days without improvement.On the 4th day, a temporary dialysis catheter was inserted into the patient¿s right internal jugular vein without incident.After 4 days of hemodialysis, the patient's symptoms of cough and dyspnea improved.It was then decided to use a chronic dialysis catheter as the patient's vascular condition was too poor to allow an arteriovenous fistula operation.The blood flow in both the arterial and venous end of the catheter was fluent after the placement of dialysis catheter manipulation.Hemodialysis was begun and after 2 hours, the patient¿s blood volume was 120 ml/min and she felt compression on her chest.A routine blood test showed hemoglobin decreased from 80 to 51 g/l.Chest radiography revealed right pleural effusion and chronic catheter located in the patient¿s right internal jugular.After a red blood cell suspension transfusion, the patient¿s hemoglobin increased to 110 g/l.During the subsequent 2 weeks (from day 8 to day 22), hemodialysis was attempted 6 times but failed one hour after the start, because the patient¿s blood volume was too low.A second chest radiograph again showed the chronic catheter in the right internal jugular vein and right pleural effusion remained.Chest computed tomography (ct) on day 22 revealed that the chronic catheter was located on the right front of the spinal column and out of the superior vena cava; the right pleural effusion was considered from a part of hematocele.A superior vena phlebography was conducted and the tip of the dialysis catheter was found on the plane of bronchial bifurcation.A guidewire was re-inserted via the dialysis catheter into the vein and the catheter was retraced.Angiography was performed synchronously until the tip of the catheter accessed the right internal jugular vein.The dialysis catheter had penetrated the posterior wall of the right internal jugular vein and was accidentally inserted into the upper mediastinum, resulting in a long and narrow sinus tract.A 4f catheter was introduced into the sinus tract via the dialysis catheter following the guidewire and a pair of spring coils (8 mm¿15 cm) was released to close the sinus tract.Then the guidewire was put back into the superior cava vena and the dialysis catheter advanced into the superior cava vena.An angiograph confirmed that the chronic catheter was then located in the superior cava vena and the sinus tract was completely closed.After this procedure, the chronic dialysis catheter was successfully used for hemodialysis and the blood flow volume was 250 ml/min.Continuous monitoring of hemoglobin showed a stable value of 110 g/l.The patient¿s feeling of compression on the chest and dyspnea disappeared.One year later, the follow-up indicated that the hemodialysis catheter was functioning well.The chest radiography showed that the location of the spring coils had not changed.Increased incidences of complications can be due to operators¿ inexperience; a consistent association between less experience and the rate of complications has been reported.It was mentioned that the patient being stout with a high bmi>24 and the patient's age, are also risk factors for catheterization complications.Although accidental puncture and perforation of blood vessels or injury to nearby structures often results in catastrophe, perforation of the posterior wall of the right internal jugular vein was directly blocked by the dialysis catheter, and a fatal hemorrhage did not occur.The present case report also highlights the limitation of chest radiography for confirming catheterization position.Also, skin expansion with dilation should be given more attention and that the dilator should be conducted gently as this may also decrease the rate of vascular wall perforation.

• 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 ; CR 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CR 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire st.; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 10326521
• MDR Text Key: 200835362
• Report Number: 3009211636-2020-00151
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2020

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: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/27/2020
• 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): Other
• Patient Age: 79 YR