MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY VENTRICLEAR COOK CATHETER EVD 5 PK; CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)

Model Number NVVDC01ABRM

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the doctor felt that the product had changed in the last couple of months.There had been leaking of cerebrospinal fluid around the catheter where the stitches are placed.They also noted that it felt like a new softer material.Additional information received reporting that the leak was from the skin exit site and had nothing to do with the connections.

• Brand Name: VENTRICLEAR COOK CATHETER EVD 5 PK
• Type of Device: CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10774871
• MDR Text Key: 214800500
• Report Number: 2021898-2020-00277
• Device Sequence Number: 1
• Product Code: NHC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NVVDC01ABRM
• Device Catalogue Number: NVVDC01ABRM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2020
• 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