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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 12/30/2013

Event Type  Injury  

Manufacturer Narrative

It is not clear at this point if the device and/or lot information is available.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If the device is returned the complaint will be investigated and a follow up report will be filed.If lot information does becomes available and if the record review indicates that there was a non-conformity a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.Device not available.

Event Description

In the literature article ¿use of a cyanoacrylate skin adhesive to reduce external ventricular drain infection rates¿ published j neurosurg 121:189¿194, 2014, it was reported that 43 unidentified patients who received bactiseal evd catheters developed infection post implantation.Once infection was identified and catheters were reviserd/emoved and antibiotic therapy was initiated.Per the article: ¿object.Ventriculitis related to external ventricular drain (evd) placement is a significant source of morbidity in neurological intensive care patients.Current rates of evd-related infections range from 2% to 45% in the literature.The authors sought to determine if a 2-octyl cyanoacrylate adhesive would result in lower infection rate than standard semi-occlusive dressings.Methods.The authors tracked ventriculitis rates via csf cultures among 259 patients whose evd sites were dressed with sterile semi-occlusive dressings and underwent routine sterile dressing exchanges every 48 hours.They analyzed data obtained in an additional 113 patients whose evd sites were dressed one time with a surgical adhesive, 2-octyl cyanoacrylate.All evd catheters were codman bactiseal devices.Results.Ventriculitis rate in patients with standard bio-occlusive dressings and wound care was 15.1%, whereas that in patients with a 2-octyl cyanoacrylate dressing was 3.54% (p = 0.002).Staphylococcus genus accounted for 79.5% of instances of ventriculitis among patients with bio-occlusive dressings and routine wound care, whereas it accounted for 25.0% of the instances of ventriculitis among patients with a liquid polymer sealant dressing.A 90% reduction in staphylococcus infection completely accounts for the observed effect (p = 0.04).Conclusions.The one-time application of 2-octyl cyanoacrylate to evd wounds and exit sites provided superior protection against evd-related ventriculitis compared to conventional evd-site wound care.Likely this protection results from a barrier to the entry of gram-positive skin flora along the evd exit tract.¿ at the time of complaint entry there is no catalogue or lot number information available.This submission is related to a literature article discovered in an effort to support the cer submission process, as such, the associated time frame of event dates includes but is not limited to 20 years.

• Brand Name: UNK BACTISEAL CATHETER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 7112015
• MDR Text Key: 94632943
• Report Number: 1226348-2017-10981
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/13/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention