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

Model Number	44010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2018
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 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.
Additional Manufacturer Narrative
Patient weight provided.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 reservoir fracture was unknown.
Additional 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
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7487979
• Report Number: 2021898-2018-00237
• Device Sequence Number: 19186629
• Product Code: LKG
• UDI-Device Identifier: 00643169497108
• UDI-Public: 00643169497108
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K874468
• 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,Followup
• Report Date (Section B): 08/15/2018

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 06/04/2018; 08/14/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 07/01/2018; 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 75