MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 60CM; CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM

Model Number	48409
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Staphylococcus Aureus (2058); Sepsis (2067)
Date of Event	11/15/2017
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
It was reported the physician admitted the patient due to an infection and ventriculitis.The physician did blood tests and confirmed that it was a staph infection.The manufacturer representative was in theatre and opened the products in theatre.It was stated the products were handled correctly.The patient's status was alive-no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported the cause of the infection was unknown.It was also stated the infection was sepsis.The current status of the patient was reportedly unknown.

• Brand Name: DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 60CM
• Common Device Name: CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7108390
• Report Number: 2021898-2017-00645
• Device Sequence Number: 111715
• Product Code: MAJ
• UDI-Device Identifier: 00643169466319
• UDI-Public: 00643169466319
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K911382
• 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): 02/08/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 48409
• Device Catalogue Number: 48409
• Device Lot Number: E10152
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 02/08/2018
• 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; Life Threatening
• Patient Age: 43 YR
• Patient Weight: 88