MAUDE Adverse Event Report: UNK BACTISEAL EVD 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 02/09/2013

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 ¿antibiotic-impregnated versus silver-bearing external ventricular drainage catheters: preliminary results in a randomized controlled trial¿ published neurocrit care (2013) 18:161¿165, doi 10.1007/s12028-013-9816-3, it was reported that after use of unknown bactiseal evd catheters, there were 5 reports of infection, 1 report of malplacement and 3 reports of hemorrhage.There was device revision in all of the infection cases, revision in the malplacement event and revision in 2 of the hemorrhage events.A single hemorrhage event was not revised.Per the article: ¿background evaluation of antibiotic-impregnated (ai) and ionized silver particle coated external ventricular drainage catheters (evd) in patients with subarachnoid (sah) or intracranial hemorrhage (ich).Methods between february 2011 and june 2012, 40 patients with acute hydrocephalus due to sah, ich or intraventricular hemorrhage were enrolled in a prospective, randomized, mono-center pilot study.Primary endpoints were defined as: number of events of cerebrospinal fluid (csf) infections.Secondary endpoints were defined as: neurosurgical complications following the placement of the evd, number of revisions of evd catheters, and cost effectiveness.Results sixty-one evd placements in 40 patients, 32 antibiotic-coated (bactiseal), 29 silver-bearing catheters (ventriguard), have been performed.Confirmed or high suspicion of csf infections occurred in 11 out of 61 events (confirmed infection: probable infection: p = 0.90).Revisions of evd were needed in 13 cases (22 %) due to csf infection, dysfunction, impaired healing, or malplacement.Conclusion regarding csf infection rate and dysfunction, no statistical significant differences between the two evd catheters bactiseal versus ventriguard were found.The silver-bearing catheter might offer a safe and cost-conscious alternative to the ai catheter.¿ 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 EVD CATHETER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 7110977
• MDR Text Key: 94633533
• Report Number: 1226348-2017-10977
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• 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: 11/16/2017
• Initial Date FDA Received: 12/12/2017
• 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