MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-C

Device Problems Disconnection (1171); Malposition of Device (2616); Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 09/22/2017

Event Type  Injury  

Manufacturer Narrative

Age/date of birth.Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided.Sex.Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided.Date of event.Please note that this date is based off the date of publication of the article as the actual event date was not provided.If information is provided in the future, a supplemental report will be issued.

Event Description

Patrick schuss, christian wispel, valeri borger, ági güresir, hartmut vatter, erdem güresir.Accuracy and safety of ventriculostomy using two different procedures of external ventricular drainage: a single-center series.Journal of neurological surgery 79 (2018).Doi: 10.1055/s-0037-1606544.Abstract: background and study aims patients with acute hydrocephalus are treated by either insertion of a conventional external ventricular drain (evd) or percutaneous needle trephination (pnt) at our institution, depending on the acuteness of intervention and the severity of illness.We compared both procedures regarding accuracy and safety necessitating surgical revision of evd or pnt.Methods between january 2012 and january 2014, 451 ventriculostomies were performed in 301 patients at our institution.All patients underwent routine computed tomography after insertion of the ventricular drain during the treatment course.Patient characteristics, underlying pathology, ventriculostomy modality, radiologic features, catheter tip location, and treatment-related complications were analyzed.Results a total of 307 of 451 ventriculostomy procedures (68%) were performed as conventional evd, and 144 (32%) were performed as pnt.Overall, 11% of patients with conventional evd underwent surgical revision due to lacking accuracy, infection, or hemorrhage; 7% of patients with pnt underwent surgical revision (p ¼ 0.2).However, multivariate analysis revealed that only ¿hospital stay > 21 days¿ as an independent variable was significantly associated with surgical revision after ventriculostomy.Conclusion the present data indicate that pnt has a similar safety profile in emergency situations in critically ill patients who need immediate treatment for acute hydrocephalus when compared with the conventional evd procedure.Reported events.A total of 5 conventional evd patients underwent surgical revision due to catheter tip misplacement.A total of 16 conventional evd patients underwent surgical revision due to catheter dislocation during their treatment course.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN CATHETER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7732393
• MDR Text Key: 115468007
• Report Number: 2021898-2018-00378
• Device Sequence Number: 0
• Product Code: JXG
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

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 Model Number: UNKNOWN-C
• Device Catalogue Number: UNKNOWN-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR