MAUDE Adverse Event Report: GMS CAMINO FLEX TUNNELED VENTRICULAR CATHETER

Catalog Number VTUN

Device Problems Unable to Obtain Readings (1516); Data Problem (3196); Patient Data Problem (3197)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/16/2016

Event Type  malfunction  

Event Description

It was reported that the vtun stopped monitoring the patient's intracranial pressure (icp).The ventrix had no transducer.The patient's icp was not monitored for several hours.The product was still implanted in the patient at the time of the report.Additional information has been requested.

Manufacturer Narrative

Correction: initial mdr was submitted with integra facility (b)(4).Product id vtun is registered under integra (b)(4).Integra has completed their internal investigation on 04may2016.The product was not returned/received for evaluation.No lot and serial number was provided by the customer; hence the dhr could not be performed.No trend could be determined for this failure mode.The root cause could not be confirmed; the product was not returned by the customer.

• Brand Name: CAMINO FLEX TUNNELED VENTRICULAR CATHETER
• Type of Device: CAMINO FLEX
• Manufacturer (Section D): GMS; dorfstrasse 2a; dorfstrasse 2a; mielkendorf D2247 ; GM D2247
• Manufacturer (Section G): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5606202
• MDR Text Key: 44454078
• Report Number: 9612007-2016-00007
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K133754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VTUN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1