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

Model Number 48409

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Staphylococcus Aureus (2058); Sepsis (2067)

Event Date 11/15/2017

Event Type  Injury  

Manufacturer Narrative

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

Event 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.

Manufacturer Narrative

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

Event 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
• Type of Device: CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7108390
• MDR Text Key: 94514263
• Report Number: 2021898-2017-00645
• Device Sequence Number: 1
• Product Code: MAJ
• UDI-Device Identifier: 00643169466319
• UDI-Public: 00643169466319
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K911382
• 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
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• Date Device Manufactured: 03/04/2016
• 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; Life Threatening
• Patient Age: 43 YR
• Patient Weight: 88