• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UKNOWN BACTISEAL CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

UKNOWN BACTISEAL CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Device Problems Excess Flow or Over-Infusion (1311); Device Operational Issue (2914); Device Dislodged or Dislocated (2923)
Patient Problems Wound Dehiscence (1154); Death (1802); Unspecified Infection (1930)
Event Date 10/01/2016
Event Type  Death  
Manufacturer Narrative
Udi: unknown part number, udi unavailable. It has been communicated that the device and/or lot information is not available for evaluation. Without the device and/or lot information it is not possible for codman to conduct a proper investigation. If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed. Trends will be monitored for this and similar complaints. At the present time this complaint is considered closed. Device not available.
 
Event Description
In the literature article ¿ventriculoatrial shunts in adults, incidence of infection, and significant risk factors: a single-center experience. ¿ published world neurosurgery. 94 (pp 345-351), 2016. Date of publication: 01 oct 2016. , the authors present experience with ventriculoatrial (va) shunts by analyzing the incidence of shunt infections and predisposing cofactors. 255 patients (145 women and 110 men) underwent 259 va shunt operations for the first time. The minimum age was 19 years, the maximum age was 84 years, and the mean age was 59. 1 years. The shunt surgery was performed 65 times by residents, 112 times by specialists, and 82 times by consultants. During the same period, 82 vp shunts were implanted. The causes of the hydrocephalus were post-hemorrhagic hydrocephalus (82/32. 2%), idiopathic and secondary normal pressure hydrocephalus (67/26. 3%), tumors (37/14. 5%) and posttraumatic hydrocephalus (36/14. 1%). The external jugular vein or the facial vein was used for distal catheter insertion to the atrium. All patients scheduled for shunt surgery were investigated for foci of infection. Preoperatively, the laboratory parameters c-reactive protein and white blood cell count were within the normal range. If an evd was implanted previously, 2 or more negative csf cultures of bacterial growth were obligatory. The csf shunt device used in all patients was the codman hakim programmable valve (johnson & johnson). The infection rate was calculated and the predisposing cofactors age, gender, cause of the hydrocephalus, previous external ventricle drainage, antibiotic impregnated catheters, the number of revisions, the educational level of the surgeons, and the duration of the operations were analyzed. Two observation times were stratified. No cardiovascular complications like embolism, heart failure, pulmonary hypertension, or infective endocarditis that was directly attributed to shunt placement were detected. Of the 255 patients, 18 (7. 1%) had infection. Sixteen patients developed deep infections, including 1 patient with shunt nephritis, and 2 developed superficial infections. Both superficial infections occurred on the basis of wound dehiscence, which occurred in 17 patients (6. 6%). In 15 cases, the shunt system was removed and an evd inserted, whereas 3 cases were treated with systemic antibiotics only. One patient died of the consequence of shunt nephritis 5 years after implantation. The total number of revision procedures was 128, resulting in a cumulative revision rate of 50. 2%. A total of 176 patients (69%) did not need a revision. The major causes of revision were dislocation in 18. 9%, over-drainage in 15. 6%, wound dehiscence in 15. 6%, infection in 9. 8%, obstruction in 5. 8%, and shunt dysfunction in 13. 7%. Furthermore, invasive shunt tests in case of suspicion of shunt dysfunction accounted for 6% and shunt ligature as a consequence of overdrainage accounted for 4. 6% at the time of complaint entry no device specific information, i. E. Catalogue/lot number, is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUKNOWN BACTISEAL CATHETER
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6189090
MDR Text Key62836528
Report Number1226348-2016-10869
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/20/2016 Patient Sequence Number: 1
-
-