MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF VENTRICULAR PORT, 16 MM, SIDE INLET; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR

Model Number 44010

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during the implant procedure, it was found that there was a fracture in the reservoir.The port was replaced and there was no injury to the patient.

Manufacturer Narrative

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

Event Description

Additional information received reported the cause of the reservoir fracture was unknown.

Manufacturer Narrative

The returned port did not meet the requirements for leak testing due to a tear in the top of the reservoir.It is unknown how or when the damage occurred.There was also proteinaceous debris observed within the interior and exterior of the port.The returned catheter was patent and met the requirements for leak testing.The instructions for use (ifu) that accompany the device caution that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components.¿ the ifu also caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ all ports and catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CSF VENTRICULAR PORT, 16 MM, SIDE INLET
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR
• 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: 7487979
• MDR Text Key: 107450538
• Report Number: 2021898-2018-00237
• Device Sequence Number: 1
• Product Code: LKG
• UDI-Device Identifier: 00643169497108
• UDI-Public: 00643169497108
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K874468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 44010
• Device Catalogue Number: 44010
• Device Lot Number: E34990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2017
• 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 Age: 42 YR
• Patient Weight: 75