MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA SNAP SHUNT ASSEMBLY; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number 24027-5

Device Problems Leak/Splash (1354); Device Or Device Fragments Location Unknown (2590)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 12/16/2016

Event Type  Injury  

Manufacturer Narrative

The product testing is in progress.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported to medtronic neurosurgery the patient underwent a procedure to replace the device with a device with less resistance.According to the report, during the procedure, the physician noticed small amounts of cerebrospinal fluid around the device and wanted it examined for perforation.Reportedly, there was a partial explant of the device and there was no injury to the patient.

Manufacturer Narrative

Additional information received reported that the partial explant was in reference to only a part of the shunt assembly being removed.According to the report, the valve was replaced and both the proximal and distal catheter remained implanted.The returned valve was patent.It met the requirements for siphon, reflux, pressure-flow, and preimplantation testing.There was proteinaceous debris observed within the interior and exterior of the valve.The valve did not meet the requirements for leak testing due to a tear noted in the top of the delta chamber.It is unknown how or when this damage occurred.The instructions for use (ifu) that accompany the device caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ the ifu also caution that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, or crushing of components.¿ a review of the manufacturing showed no anomalies.All valves are 100% tested at the time of manufacture.

Manufacturer Narrative

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

• Brand Name: DELTA SNAP SHUNT ASSEMBLY
• 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: bob shokoohi ; 125 cremona drive; goleta, CA 93117 ; 8055718725
• MDR Report Key: 6248386
• MDR Text Key: 64710595
• Report Number: 2021898-2017-00014
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K902783
• 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,Followup,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 24027-5
• Device Lot Number: D50811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2014
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR