MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL VALVE, BURR HOLE, 16 MM, LOW PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 42542

Device Problem Complete Blockage (1094)

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

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 was in the or for shunt installation.They prepared the valve, (filling the valve with normal saline preservative free) and connected the valve to the ventricular catheter.The doctor watched the csf coming out from the distal end of the valve and there was nothing coming back.They disconnected the valve and refilled the valve again making sure there was no air in the reservoir.They reconnected the valve, and there was no csf coming out of the valve.The doctor took another valve and it did the same thing.They decided to use a strata burr hole valve, and set it up at the same level, and the csf was flowing easily form the distal end of the valve.The 2 valves were thrown in the garbage, and the 2 remaining valves are being retrieved from the hospital and will be returned for analysis.The patient got a programmable valve and they were doing fine.It was noted that the manufacturer's representative met with the neurosurgeon, and they tested 1 of the 2 remaining valves with the same serial number, and it appeared that the proximal end was not flowing.The doctor thinks that the proximal end was blocked because when why were filling the valve with the proximal end in the ns and not the distal, the valve could not be filled.

• Brand Name: CSF-FLOW CONTROL VALVE, BURR HOLE, 16 MM, LOW PRESSURE
• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9789223
• MDR Text Key: 196423660
• Report Number: 2021898-2020-00081
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169466043
• UDI-Public: 00643169466043
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K831678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 42542
• Device Catalogue Number: 42542
• Device Lot Number: E37412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2020
• Date Device Manufactured: 01/26/2018
• 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