MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN VENTRICLEAR CATHETER; CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC O

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Philipp spindler, ingo fiss, henrik giese, elvis hermann, johannes lemcke, martin u.Schuhmann, ulrich-wilhelm thomale, andreas schaumann.Angulation toward coronal convexity measure and catheter length indication improves the quality of ventricular catheter placement a smartphone-assisted guidance technique.World neurosurgery (2022).Doi: 10.1016/j.Wneu.2021.12.036.Background: accurate placement of a ventricular catheter (vc) is crucial to reduce the risk of shunt failure.In the randomized, prospective, multicenter gavca (guided application of ventricular catheters) trial, which evaluated the quality of vc placement, the subgroup of patients with detailed length-marked vcs (dvcs) reflected a difference in the primary endpoint of optimal vc placement compared with the subgroup of patients with simplified length marked vcs (svcs).The objective of the present analysis was to compare the dvc and svc groups and the smartphone-assisted guidance technique (ga) with the standard freehand technique (fh) for vc placement.Methods: we performed a further analysis of the gavca trial in 2 steps.First, we compared the dvcs, which provided a detailed distance from the tip to the base (3-13 cm) in 0.5-cm intervals, with the svcs with a length indication at 5 and 10 cm from the tip to base.Second, we compared the ga technique with the fh in the dvc group.Results: the data from 137 patients (104 dvc patients vs.33 svc patients) were eligible for the present analysis.Optimal vc placement was achieved in 72.1% of the dvc group and 39.4% of the svc group (odds ratio, 3.9; 95% confidence interval, 1.7e9.3; p 0.001).In addition, we performed a subgroup analysis of the 104 dvc patients concerning the accuracy of catheter placement using 2 different techniques (ga, n 54; and fh, n 50).Optimal catheter placement was achieved in 81.5% of the ga group and 62.0% of the fh group (odds ratio, 2.7; 95% confidence interval, 1.1e6.8; p 0.03).Vc placement using the ga technique was successful in all patients at the primary puncture.In contrast, for 8.7% of the patients in the fh group, multiple attempts were necessary (p 0.03).Conclusions: the results from the present analysis suggest that the combination of a ga technique and the use of a dvc will improve the rate of accurate vc placement.Compared with the fh technique, patient safety was increased by the reduction of unsuccessful vc placement attempts using the ga technique and dvcs.Reported events: an incorrect catheter position had occurred in 36.4% of the svc group.Incorrect catheter positioning was defined when the vc position was grade iii or iv, not ipsilateral, or when multiple punctures were necessary.

• Brand Name: UNKNOWN VENTRICLEAR CATHETER
• Type of Device: CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC O
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13535720
• MDR Text Key: 293096025
• Report Number: 2021898-2022-00065
• Device Sequence Number: 1
• Product Code: NHC
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 02/15/2022
• 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