MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EDM VENTRICULAR CATHETER, LARGE DIAMETER, 35 CM; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	27703
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2018
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 catheter was leaking.No patient symptoms or complications were reported and the patient¿s status was listed as no injury.
Additional Manufacturer Narrative
Approximately 33 cm of the edm ventricular catheter was returned.The catheter was patent and met the requirements for leak testing.Therefore the conditions of the complaint could not be duplicated by laboratory personnel.Proteinaceous debris was observed within the interior and exterior of the catheter.All catheters are 100% inspected at the time of manufacture.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 leaking was not determined.

• Brand Name: EDM VENTRICULAR CATHETER, LARGE DIAMETER, 35 CM
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7308773
• Report Number: 2021898-2018-00110
• Device Sequence Number: 13756193
• Product Code: GWM
• UDI-Device Identifier: 00643169496880
• UDI-Public: 00643169496880
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K984053
• 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): 03/20/2018

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: 05/31/2022
• Device Model Number: 27703
• Device Catalogue Number: 27703
• Device Lot Number: E34690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1