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

Catalog Number 44010

Device Problem Break (1069)

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

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

The returned port met the requirements for leak testing.There was proteinaceous debris observed within the interior and exterior of the valve.The returned catheter was patent and met the requirements for leak testing and there was no crack observed on the proximal end of the catheter.Therefore the conditions of the complaint could not be duplicated by laboratory personnel.A review of the manufacturing records showed no anomalies.All ports and catheters are 100% inspected at the time of manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported to medtronic neurosurgery that the device was found to be cracked preoperatively.According to the report the doctor used a new device to complete the surgery.Reportedly, there was no injury to the patient.

Manufacturer Narrative

The returned port met the requirements for leak testing.There was proteinaceous debris observed within the interior and exterior of the valve.The returned catheter was patent and met the requirements for leak testing and there was no crack observed on the proximal end of the catheter.Therefore the conditions of the complaint could not be duplicated by laboratory personnel.A review of the manufacturing records showed no anomalies.All ports and catheters are 100% inspected at the time of manufacture.Additional patient/device information: the patient's weight has been provided.It was reported that the patient is currently doing well.It was also later reported that there was no crack found to be on the ventricular catheter.

Manufacturer Narrative

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

• Brand Name: CSF-VENTRICULAR PORT, 16MM SIDE INLET CONNECTOR
• 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: bob shokoohi ; 125 cremona drive; goleta, CA 93117 ; 8055718725
• MDR Report Key: 6060833
• MDR Text Key: 58919616
• Report Number: 2021898-2016-00393
• Device Sequence Number: 1
• Product Code: LKG
• 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: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 44010
• Device Lot Number: E05897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• 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: 52 YR
• Patient Weight: 65