MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC.

Catalog Number UNK CATHETER

Device Problem Use of Device Problem (1670)

Patient Problems Cerebrospinal Fluid Leakage (1772); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Unspecified Infection (1930)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

Udi -- unknown part number, attempts to obtain product were unsuccessful, udi unavailable.Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

Event Description

In the literature article ¿the aalborg bolt-connected drain (abcd) study: a prospective comparison of tunneled and bolt-connected external ventricular drains¿ by asaad s.K.And bjarkam c.R., published acta neurochirurgica.161 (1) (pp 33-39), 2019, it was reported that after implant of unknown codman evd catheters, 21 patients had complications including: csf leakage, accidental discontinuation, placement-related intracranial haemorrhage, malfunction, migration, infection and revision.Per the abstract: ¿background: acutely increased intracranial pressure (icp) is frequently managed by external ventricular drainage (evd).This procedure is life-saving but marred by a high incidence of complications.It has recently been indicated that bolt-connected external ventricular drainage (bc-evd) compared to the standard technique of tunnelled evd (t-evd) may result in less complications.Aim(s): to prospectively sample and compare two cohorts by consecutive allocation to either bc-evd or t-evd from the introduction of the bc-evd technique in our department and 12 months onward.Method(s): patients undergoing ventriculostomy between the 1st of march 2017 and the 28th of february 2018 were considered for inclusion.The neurosurgeon on-call sovereignly set the indication and decided on evd type (bc-evd or t-evd), consequently resulting in two cohorts as 3/7 senior neurosurgeons on call were open to the use of bc-evd, while 4/7 were reluctant to use this technique.Data was continuously collected using patient records, including results of cerebrospinal fluid (csf) culturing and available ct/mri-scans.Recorded complications included csf leakage, accidental discontinuation, placement-related intracranial haemorrhage, malfunction, migration, infection and revision.Result(s): forty-nine evds (32 t-evds/17 bc-evds) were included; 19/32 (59.4%) t-evds and 3/17 (17.6%) bc-evds were found to have complications (p = 0.007).The relative risk of complications when using t-evd was 3.4 times that of bc-evd.Conclusion(s): ventriculostomy by bc-evd compared to t-evd reduces incidence and risk of complications and should be the first choice in evd placement.That said, t-evd has a role in paediatric patients and for intraoperatively and occipitally placed evds¿ at the time of complaint entry, no patient or device specific information, i.E.Catalogue/lot number, is available.This article was discovered through the monthly review.

• Brand Name: NI
• Type of Device: NI
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; rue girardet 29; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC.; rue girardet 29; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: karen anigbo ; 11 cabot boulevard; mansfield, MA 02048 ; 7819715608
• MDR Report Key: 8412338
• MDR Text Key: 138530644
• Report Number: 1226348-2019-10167
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CATHETER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/12/2019
• 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): Other