MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY VENTRICULAR CATHETER, STANDARD, BARIUM IMPREGNATED, 23 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 41101

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

Patient Problems Unspecified Infection (1930); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that following the implant of the catheter, there was wound leakage.It was determined that the ventricle had become infected.The catheter was removed from the patient and both debridement and a bacterial culture were done.Medication was also administered to control the intracranial infection.The catheter was to be replaced in the future.

Manufacturer Narrative

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

Event Description

Additional information received reported the doctor doubted that the reason for the infection was the catheter.The doctor reportedly found that the ¿catheter bayonet edge¿ was sharp and could puncture the catheter and cause a secondary infection.

Manufacturer Narrative

Approximately 6.5 cm of the ventricular catheter was returned.The returned catheter was patent.However the catheter did not meet the requirements for leak testing.It is unknown how or when the damage occurred.The edge of the catheter appears jagged.The instructions for use (ifu) that accompany the device caution that ¿low tear strength is a characteristic of most unreinforced silicone elastomer materials.Care must be taken with the handling and placement of the silicone elastomer catheter tubing to avoid cuts, nicks or tears.¿ 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.

• Brand Name: VENTRICULAR CATHETER, STANDARD, BARIUM IMPREGNATED, 23 CM
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• 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: 7175016
• MDR Text Key: 96733445
• Report Number: 2021898-2018-00012
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169466500
• UDI-Public: 00643169466500
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K792007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 41101
• Device Catalogue Number: 41101
• Device Lot Number: E16426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2017
• Initial Date FDA Received: 01/09/2018
• Supplement Dates Manufacturer Received: 01/23/2018; 05/03/2018
• Supplement Dates FDA Received: 02/22/2018; 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2016
• 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; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 47