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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR UNKNOWN BACTISEAL CATHETER KIT

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INTEGRA LIFESCIENCES SWITZERLAND SAR UNKNOWN BACTISEAL CATHETER KIT Back to Search Results
Catalog Number XXX- BACTISEAL CATHETER
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  Injury  
Manufacturer Narrative
Attempts are being made to obtain additional information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
In the literature article, " surgical management of giant retrocerebellar arachnoid cysts with a cystoventricular stent after long-term. " by amir kershenovich, sheela vivekanandan, xin s. Xin and caitlin davenport. It was reported that one patient out of the five had surgical complications with the codman bactiseal ventricle catheter. Per the article: "background: outcomes of surgical treated patients with giant retrocerebellar arachnoid cysts with the available typically preferred techniques frequently are unsatisfactory. Objectives: we hypothesized that a pressure gradient may exist between the cyst and the ventricular system that may be responsible for the posterior fossae-related symptoms and headaches, and, if so, that connecting both cavities by means of a shunt catheter (i. E. , cystoventricular stent), the pressure differences would equilibrate and the symptoms resolve. To prove our hypothesis, we decided to simultaneously monitor the intracyst pressure and the intraventricular pressure. Methods: this was a retrospective chart review analysis of 5 consecutive patients with giant retrocerebellar arachnoid cysts treated between 2014 and 2016. Results: four patients underwent 3 days of continuous intracranial pressure monitoring, and 1 patient was monitored in the surgical suit. Cyst and ventricular pressures tended to be within normal accepted values in all patients, and a pressure gradient was noticed only in the 2 patients with previous cyst surgeries. All patients were treated with a cystoventricular stent, and overall, had long-term sustained good outcomes, with resolution of symptoms in 3 and significant improvement in 2. Conclusions: patients with symptomatic large retrocerebellar arachnoid cysts do not seem to have increased intracranial pressure, and regardless of the presence or absence of a pressure gradient between the cyst and the ventricles, a cystoventricular stent seems to be effective and the best first surgical option to offer. Patient harm: patient 5, age (b)(6) female, had surgical complications. The patient had ventricle catheter malposition and thalamic hemorrhage. There were no reports of product malfunction.
 
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Brand NameUNKNOWN
Type of DeviceBACTISEAL CATHETER KIT
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
rue girardet 29
le locle
SZ
Manufacturer (Section G)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
ch-2400
le locle
SZ
Manufacturer Contact
vivian nelson
325 paramount drive
raynham, MA 02767
6099362319
MDR Report Key8737107
MDR Text Key149330961
Report Number1226348-2019-00247
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberXXX- BACTISEAL CATHETER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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