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

Catalog Number	27637
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the edm ventricular catheter was returned.The catheter was patent and met the requirements for leak testing.A review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of manufacture.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 air was trapped within the catheter and could not be eliminated during the procedure.According to the report, the catheter was replaced and there was no injury to the patient.
Additional Manufacturer Narrative
Additional information received reported the cause of the air being trapped in the catheter was unknown.It was stated the catheter did not have patient contact.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EDM VENTRICULAR CATHETER TRANSLUCENT, 35 CM
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6695195
• Report Number: 2021898-2017-00363
• Device Sequence Number: 16336638
• Product Code: GWM
• UDI-Device Identifier: 00643169497078
• UDI-Public: 00643169497078
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K802100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2017

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: 01/31/2021
• Device Catalogue Number: 27637
• Device Lot Number: E09601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2017
• Supplement Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1