MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY VENTRICULAR CATHETER WITH BIOGLIDE, STANDARD, 23 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	91503
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The ventricular catheter was part of a revision surgery.The director had advised that the ventricular catheter should not be pulled out of the ventricle to avoid a possible cerebral hemorrhage.The ventricular catheter was cut off, and the interface was ligated directly.
Additional Manufacturer Narrative
Handling of the returned product could not be performed due to excessive blood clots and biological debris present on the interior and exterior surface of the valve and catheter system.Decontamination and analysis could not be performed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENTRICULAR CATHETER WITH BIOGLIDE, STANDARD, 23 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 9439107
• Report Number: 2021898-2019-00432
• Device Sequence Number: 3389290
• Product Code: JXG
• UDI-Device Identifier: 00643169466289
• UDI-Public: 00643169466289
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K951258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 91503
• Device Catalogue Number: 91503
• Device Lot Number: E28907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention