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

Model Number	27816
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a patient with hydrocephalus was taken to surgery for insertion of a right ventriculoperitoneal shunt.The previously placed external ventricular drain was removed.The physician used an ultrasound to guide placement of a ventricular catheter.Clear fluid cam out initially, but the flow was not excellent.The catheter was revised, and another test was done of the distal runoff.No results with multiple pumping and aspiration attempts.The physician interrogated the proximal catheter with a 23 gauge butterfly needle, and there was excellent flow.It was evident that the valve was not functioning properly.The physician disconnected the snap top reservoir from the proximal catheter and removed the entire distal system including the valve and distal catheter and replaced it with a new system.Immediately, clear fluid was visualized coming out at the distal end tubing.

• Brand Name: STRATA II SNAP SHUNT ASSEMBLY, SMALL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8019613
• Report Number: 2021898-2018-00523
• Device Sequence Number: 1382518
• Product Code: JXG
• UDI-Device Identifier: 00643169975606
• UDI-Public: 00643169975606
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 27816
• Device Catalogue Number: 27816
• Device Lot Number: E48249
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 MO
• Patient Weight: 9