MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EDM VENTRICULAR CATHETER, TRANSLUCENT, 35 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	26020
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned catheter was patent and it met requirements for the leak testing.Therefore, the conditions of the complaint could not be duplicated by laboratory personnel.There was proteinaceous debris observed within the catheter.A review of the manufacturing records showed no anomalies.All catheters are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to medtronic neurosurgery that the patient's primary disease was craniocerebral trauma.According to the report, post-operative observation found leakage of the ¿drainage tube¿ causing the patient's ventricle to become a "cavity." reportedly, the physician replaced with a new ¿tube,¿ and the patient's current status was normal.
Additional Manufacturer Narrative
The returned catheter was patent and it met requirements for the leak testing.Therefore, the conditions of the complaint could not be duplicated by laboratory personnel.There was proteinaceous debris observed within the catheter.A review of the manufacturing records showed no anomalies.All catheters are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The returned catheter was patent and it met requirements for the leak testing.Therefore, the conditions of the complaint could not be duplicated by laboratory personnel.There was proteinaceous debris observed within the catheter.A review of the manufacturing records showed no anomalies.All catheters are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: EDM VENTRICULAR CATHETER, TRANSLUCENT, 35 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6620905
• Report Number: 2021898-2017-00315
• Device Sequence Number: 18994964
• Product Code: JXG
• UDI-Device Identifier: 00643169498211
• UDI-Public: 00643169498211
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup,Followup,Followup
• Report Date (Section B): 07/05/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 26020
• Device Lot Number: E11056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: 06/13/2017; 07/05/2017; 07/05/2017; 07/05/2017
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 07/02/2017; 08/01/2017; 10/04/2017; 10/05/2017
• 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; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 60