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 Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2018
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 on (b)(6) 2018, the patient was to have brain tumor surgery.During the operation, the reservoir was implanted; however, the ventricular tube broke and was immediately replaced with another device.The patient's status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
The returned port met the requirements for leak testing.There was proteinaceous debris noted within the interior and exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open affecting the flow of fluid through the valve.The instructions for use (ifu) that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system.The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization, or other debris.¿ the catheter was returned in two pieces of lengths 13 cm and 10 cm respectively.The tear site appeared to be jagged.It is unknown how or when the damage occurred.The returned segments were patent and passed leak testing when tested individually.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.¿ 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.
Additional Manufacturer Narrative
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: 7704612
• Report Number: 2021898-2018-00361
• Device Sequence Number: 996201
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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: E34897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 08/28/2018; 08/08/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 09/06/2018; 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1