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 11/08/2013

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 ¿effect of introduction of antibiotic-impregnated shunt catheters on cerebrospinal fluid shunt infection in children: a large single-center retrospective study¿ published j neurosurg pediatrics 13:101¿106, 2014, it was reported that 25 unidentified patients in the antibiotic-impregnated catheter group developed infection after insertion of unknown bactiseal catheters.Per the article: ¿object.Infection after both primary and revision shunt surgeries remains a major problem in pediatric neurosurgical practice.Antibiotic-impregnated shunt (ais) tubing has been proposed to reduce infection rates.The authors report their experience with ais catheters in their large pediatric neurosurgery department.Methods.The authors conducted a retrospective case review of consecutive shunt operations performed before (1993¿2003) and after (2005¿2009) introduction of ais tubing, with analysis of shunt infection rates and causative organisms identified.Results.The historical control group consisted of 1592 consecutive shunt operations (657 primary insertions), and the ais study group consisted of 500 consecutive shunt operations (184 primary insertions).Patients ranged in age from 0¿17 years.In the historical group, 135 infections were identified (8.4%).In the ais study group, 25 infections were identified (5%), representing a significant reduction (p < 0.005).The latency to diagnosis of infection was 23 days in the historical group and 139 days in the ais study group.The infection rates in infants 0¿6 months of age were 12.2% (historical group) and 6.7% (ais group, p < 0.005), and in infants 7¿12 months of age the rates were 7.9% (historical group) and 2.7% (ais group, p < 0.005).In the historical control group, the frequency rank order of causative organisms was coagulase-negative staphylococcus (51.9%), staphylococcus aureus (31.6%), streptococcus or enterococcus spp.(8.8%), gram-negative organisms (4.4%), and propionibacterium acnes (2.2%).Organisms responsible for infections in ais were s.Aureus (40%), followed by streptococcus or enterococcus spp.(20%), p.Acnes and coagulase-negative staphylococcus (both 16%), and gram-negative organisms (4%).No unusually antibiotic resistant bacteria were identified in either group.The authors further subdivided the ais group into those undergoing primary ais insertion (subgroup 1), those undergoing revision of non-ais systems using ais components (subgroup 2), and those undergoing revision of ais systems using ais components (subgroup 3).Infection rates were 1.6% in subgroup 1, 2.5% in subgroup 2, and 11.7% in subgroup 3.Staphylococcus aureus was the most common organism identified in infections of the subgroups 2 and 3.Conclusions.Use of ais tubing significantly improves shunt infection rates in both general pediatric and infant populations with no evidence of increased antibiotic resistance, which is in agreement with previous studies.However, the increased infection rate in revision surgery in children with ais catheters in situ raises questions about their long-term application.¿ there was no specific treatment regimen reported for the infections.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: 7111738
• MDR Text Key: 94623788
• Report Number: 1226348-2017-10979
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• 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
• Date Manufacturer Received: 11/17/2017
• 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