MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 60CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	48409
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to medtronic neurosurgery that upon opening the device, the surgeon noticed that the proximal tip of the inner plastic cannula that allows them to connect the catheter and helps assist pulling it through was broken off.
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 device had patient contact.There was no injury to the patient.

• Brand Name: DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 60CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6868875
• Report Number: 2021898-2017-00481
• Device Sequence Number: 19093003
• Product Code: JXG
• UDI-Device Identifier: 00643169466319
• UDI-Public: 00643169466319
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K911382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2017

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: 03/31/2022
• Device Model Number: 48409
• Device Catalogue Number: 48409
• Device Lot Number: E30913
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 11/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 104