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

Model Number	46866
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2018
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 the insert of the catheter passer included in the shunt kit snapped at the tip where the catheter would be connected.This happened when the surgeon attempted to release the insert tip from the handle during the procedure, prior to patient contact.It was stated no excess or unnecessary force was observed.The product was replaced and there was no injury to the patient.
Additional Manufacturer Narrative
Only the obturator was returned.The distal tip of the obturator was observed to be broken off.The site of the break had an uneven, jagged edge.It is unknown how or when this damage occurred.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA II SHUNT ASSEMBLY, REGULAR
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7316393
• Report Number: 2021898-2018-00114
• Device Sequence Number: 19233676
• Product Code: JXG
• UDI-Device Identifier: 00643169010680
• UDI-Public: 00643169010680
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2018

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: 11/30/2019
• Device Model Number: 46866
• Device Catalogue Number: 46866
• Device Lot Number: E23884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR