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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOPHYSA KUBALA EXTERNAL DRAINAGE CATHETER 35CM LENGTH
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SOPHYSA KUBALA EXTERNAL DRAINAGE CATHETER 35CM LENGTH Back to Search Results
Model Number FVPC4
Device Problem Fracture (1260)
Patient Problems Cerebrospinal Fluid Leakage (1772); Neurological Deficit/Dysfunction (1982)
Event Date 03/28/2020
Event Type  malfunction  
Event Description
When the patient bandage was removed, it was wet and it was observed that the catheter was broken between the patient scalp and the connexion to the drainage system.Catheter was therefore explanted.Patient had alertness deficiency and needed intubation.Csf leakage could have led to infection/meningitis.
 
Manufacturer Narrative
The batch file was assessed and no defects were detected in production (tensile strength were compliant).We received additional information from hospital on the (b)(6) 2020.The product was sent to another manufacturer by mistake.It explains why we didn't receive the information sooner.The returned device has been analysed: the catheter has lost its mechanical elasticity.It can no longer be compressed or stretched normally.It has become fragile.Moreover it can be seen that the catheter is bent at the connector outlet.This is an irreversible plastic deformation.Catheter breakage is a known incident for lumbar catheters but we have never received similar complaints for ventricular catheters.This phenomenon is symptomatic of prolonged contact with an iodinated disinfectant such as betadine®.Therefore ventricular catheters from the same batch were tested to check impact of bétadine on catheter properties.First test was performed using betadine applied 4 times a day on the catheter during several days but the test was eventless on the catheter.A second test was performed to reproduce hospital procedure every 2 days: betadine application, saline flushing, compress drying, betadine application, dry compress fixed with plaster and bandage around the compress in addition, to reproduce constraints applied on the catheter (from patient or users), catheter was placed in tensile strength equipment and 3000 to 5000 tensile cycles were applied per day during 14 days.In this conditions, catheter breakage was observed.It is therefore highly probable that catheter has been weakened due to a combination of several events: exposure of the catheter to povidone-iodine in a confined, poorly breathing environment.Repeated mechanical stress during use.Bent of the distal part of the catheter connected to luer connector which increased mechanical stress.Weakened catheter broke where stress was applied by connector.This situation is an isolated incident which occurred only at (b)(6), despite the use of this product over a few years without noticing any equivalent phenomenon.Among others, the contribution of a user mishandling during patient care cannot be ruled out in the root causes analysis.
 
Event Description
When the patient bandage was removed, it was wet and it was observed that the catheter was broken between the patient scalp and the connexion to the drainage system.Catheter was therefore explanted.Patient had alertness deficiency and needed intubation.Csf leakage could have led to infection/meningitis.
 
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Brand Name
KUBALA EXTERNAL DRAINAGE CATHETER 35CM LENGTH
Type of Device
KUBALA EXTERNAL DRAINAGE CATHETER 35CM LENGTH
Manufacturer (Section D)
SOPHYSA
5 rue guy moquet
orsay, 91400
FR  91400
MDR Report Key10481134
MDR Text Key206561447
Report Number3001587388-2020-20307
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K853365
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFVPC4
Device Catalogue NumberFVPC4
Device Lot Number194693B/G0026
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2020
Date Manufacturer Received05/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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