MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. STERILE MICRO PROGRAMMABLE VAL; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 0148CSD

Device Problems Material Puncture/Hole (1504); Obstruction of Flow (2423)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 04/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was returned for evaluation.The position of the cam when valve was received was at 120 mmh2o.The valve was visually inspected.It was confirmed there was a hole in the silicone housing just after the proximal connector.A review of manufacturing records found the device conformed to specification when released to stock.The root cause for the tear/cut in the silicone housing is likely due to the user.As noted in the ifu silicone has a low tear / cut resistance.Previous investigation into this issue has concluded that silicone housing tears are not design related.In order for the housing tear to occur the user has to compromise the silicone through a nick or tear in order for the event to occur.Validation testing demonstrates a robust design.Testing has shown that if the silicone housing has been compromised, a housing tear is likely to occur.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

It was reported that the hakim micro valve was obstructed post implantation and was emergently revised.The patient has exhibiting symptoms of increased intracranial pressure.Obstruction of the central catheter was noted.Disconnecting of the valve with a protected forceps (gentle disconnection by the surgeon) and replacement of the central catheter.Thereafter, testing of the peripheral catheter inclusive valve: at that point, hole in valve noted.Unclear if hole pre-existing or caused by protected forceps when disconnecting.

• Brand Name: STERILE MICRO PROGRAMMABLE VAL
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• Manufacturer Contact: karen anigbo ; 11 cabot boulevard; mansfield, MA 02048 ; 5088282726
• MDR Report Key: 7604785
• MDR Text Key: 111151612
• Report Number: 1226348-2018-10409
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K980778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 0148CSD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 1 YR
• Patient Weight: 9