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

Model Number DIALYSIS UNKNOWN

Device Problem Obstruction of Flow (2423)

Patient Problems Hemothorax (1896); Unspecified Infection (1930); Pneumothorax (2012); Thrombosis (2100)

Event Date 04/02/2019

Event Type  Injury  

Manufacturer Narrative

Title complications associated with permanent internal jugular hemodialysis catheter: a retrospective study source hyder et al.Cureus, volume 11, 2019 (1-8) article number: 4 date of publication: 22 april 2019.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

According to literature source of study performed between 2014 to the year 2015, permanent hemodialysis catheter was place in 212 patients.In 2 (two) or 0.94% of the patients had hemothorax, just after the procedure, there was opacification in the right hemithorax, which on aspiration was turned out to be blood.Chest tube drainage was arranged urgently.The patient remained stable and the chest tube was removed after one week.In 26 (twenty -ix) or 12.26% of the patients had infection, patients presented with pain, fever, redness and small pus discharge at the site of the catheter insertion.Antibiotics was given to all patients; 14 (fourteen) patients responded while the 12 (twelve) didn't respond to the antibiotics.The catheter was removed in all 12 patients who didn't respond to the antibiotics trial.The catheter tip was sent for culture and in 9 (nine) patients, the culture turned out to be staphylococcus aureus while in 3 (three) patients, it turned out to be pseudomonas.In 6 (six) or 2.83% of the patients had venous thrombosis, patients presented with facial swelling.A ct (computed tomography) scan was performed and thrombosis of the internal jugular vein was to be found.The catheter was removed, and anticoagulant treatment was given, and the patients responded well.In 5 (five) or 2.35% of the patients had catheter thrombosis.All 5 patients presented with unsuccessful hemodialysis within one month of catheter placement.In all patients, they used streptokinase to open the catheter; the trial was successful in the 3 patients while the other 2 patients, the catheter didn't open with the use of streptokinase, which result to a catheter replacement.In 2 or 0.94 of the patients had pneumothorax, in one patient, there was a small pneumothorax and no further intervention required while in one patient, the pneumothorax was large, and the patient felt shortness of breath.In this patient, the chest tube was placed, and the patient responded well, and the chest tube was removed after 8 (eight) days.

• 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
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 8953421
• MDR Text Key: 161028978
• Report Number: 3009211636-2019-00192
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: PK
• 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: 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2019
• 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
• Date Manufacturer Received: 08/08/2019
• 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): Required Intervention
• Patient Age: 58 YR