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

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

Udi: unknown product code.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.

Event Description

In the literature article abstracts from 25th congress of the european society for pediatric neurosurgery ¿ventriculo -subgaleal shunt using an antibiotic - impregnated catheter: a retrospective analysis of our institutional experience¿ published nerv syst (2016) 32:905¿1012 971, it was reported that 3 unidentified children had complications after use of bactiseal catheters; 1 hemorrhage and 2 infections.Per the article: ¿ventriculo-subgaleal shunt (vss) is a temporary measure to manage hydrocephalus, eventually overcoming the risks of external ventricular drainage and subcutaneous reservoir¿ we performed a retrospective analysis of vss performed at our institution in the period 2013-2015.Antibiotic impregnated catheter (bactiseal® , codman) along with a right angle connector were used to build a patient-tailored shunt¿ one case of hemorrhage secondary to abrupt ventricular drainage, that did not require additional surgery, and two cases of infection in patients who underwent multiple surgical procedures (including endoscopy for multiloculated hydrocephalus).All patients were converted to a permanent shunt except for 2 patients who died because of complications of prematurity and one patient who was made shunt-free with endoscopic third-ventriculostomy.¿ no further information was reported regarding the treatment or outcome of the three reported complications.No patient specific information was reported.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: 7047285
• MDR Text Key: 92587136
• Report Number: 1226348-2017-10861
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• 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: 10/30/2017
• 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