MAUDE Adverse Event Report: MEDTRONIC DOMINICANA EDM VENTRICULAR CATHETER TRANSLUCENT, 35 CM; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number 27637

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/01/2024

Event Type  malfunction  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information regarding an external drainage and monitoring system catheter.It was reported that during the surgery of ventriculocentesis, when using normal saline to check the air tightness, it was found that the catheter leaked.The catheter was replaced with a new one.The patient's medical history was communicating hydrocephalus caused by a car accident.

• Brand Name: EDM VENTRICULAR CATHETER TRANSLUCENT, 35 CM
• Type of Device: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19018553
• MDR Text Key: 339117619
• Report Number: 9612501-2024-00871
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 00763000030261
• UDI-Public: 00763000030261
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K802100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2024

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: 27637
• Device Catalogue Number: 27637
• Device Lot Number: 0224819303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/02/2024
• Date Device Manufactured: 08/03/2022
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 75 KG