MAUDE Adverse Event Report: GESELLSCHAFT FUR MEDIZINISCHE SONDENTECHNIK - N CAMINO FLEX TUNNELED VENTRICULAR CATHETER

Catalog Number VTUN

Device Problems Signal Artifact/Noise (1036); No Device Output (1435); Improper Device Output (2953)

Patient Problem No Code Available (3191)

Event Date 05/01/2015

Event Type  malfunction  

Event Description

This is the first of two reports involving a vtun and cam02 monitor from the same facility.((b)(4))."patient had an icp monitor/ evd drain placed in the evening of (b)(6) 2015.During the early morning the icps began to steadily rise to 30-50's.Stat head ct was obtained and per review with the doctor did not match the increasing icps that we were receiving after many interventions with 3%, mannitol, pentobarbital, hyperventilation, etc.Doctor was again at the bedside for interventions.Using the setup with transducer cable, prior to further intervention, icp was monitored and found to have a great wave form and readings from 5-9.Doctor was at bedside manipulating the catheter, flushing and observing the wave form, and felt these numbers to be more in line with the head ct.We continued to monitor icps using this method".Doctor said that the wave form that he was seeing on the cam02 appeared to have good form, but that there was a lot of "static" on the screen, or interference of some kind.He also told me that this vtun catheter was in a ventricle and that it was working fine for three days and then abruptly stopped working.They were still able to get a pressure and a good wave form by connecting an external transducer.Icp readings in the 40's and the patient was treated according to this number.The waveform was distorted with this reading.Fluid filled transducer was connected to flex catheter and reading was 7mmhg.Further info received on (b)(4) 2015 was as follows: a child(gender was not provided) status post total resection of solid and cystic tumor from right tegmentum.No revision was required.The unit was not explanted and there was no patient injury.Icp monitor (cam02 monitor was used with this vtun serial number (b)(4) stopped recording on (b)(6) 2015 and an error message was given on the monitor of "catheter failure"."we attempted to trouble shoot the monitor, turning it off and on, re-sync to our bedside monitor, all without success".Due to the malfunction we used a transducer cable to monitor icps.After the monitor was turned off for a time, when turning the monitor back on the error message was gone.The camino monitor was giving a reading but were different from the numbers being obtained by transducer cable by 3 5.We continued to monitor icps using the transducer method.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported info.

Manufacturer Narrative

Integra has completed their internal investigation: evaluation of actual device, review device history records.Results: the eeprom has been read out and compared to the original eeprom data.All data normal.The bridge resistance has been checked and the value is within specifications.The catheter has been checked for leakages, but the catheter body is intact.A linearity test has been conducted.All reading were within tolerance.This lot has been built in 2013 according sop with a shelf life of 12 months.Conclusion: the root cause cannot be determined at the vtun catheter.The vtun catheter worked according specifications.

• Brand Name: CAMINO FLEX TUNNELED VENTRICULAR CATHETER
• Type of Device: CAMINO FLEX
• Manufacturer (Section D): GESELLSCHAFT FUR MEDIZINISCHE SONDENTECHNIK - N; mielkendorf D2247 ; GM D2247
• Manufacturer (Section G): GMS; dorfstrasse 2a; mielkendorf D2247 ; GM D2247
• Manufacturer Contact: linda serentino ; 315 enterprise dr; 6099365560
• MDR Report Key: 4791543
• MDR Text Key: 5855439
• Report Number: 9617494-2015-00005
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: VTUN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2015
• Initial Date FDA Received: 05/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 3 YR