MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM PROGRAMMABLE VALVE, RT ANGLE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3184

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 09/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon completion of the investigation, a follow up report will be filed.

Event Description

As reported by the ous affiliate, after being implanted, a chpv and bactiseal catheter were found to not be working.The devices were removed from the patient.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).Two sets of valves and catheter combinations were returned for evaluation.This evaluation is of the valve with lot number cvlcbc, serial (b)(4) and the attached catheter.The valve and catheter were visually inspected.A hole in the needle chamber was found.The position of the cam when valve was received was 60 mmh2o.The valve was hydrated and tested for programming, with no issues found.The valve was flushed; no occlusion was noted.The valve was leak tested and only leaked from the hole in the needle chamber.The valve was reflux tested and passed.The valve was then pressure tested and passed.Evaluation of the catheter found no leakage or occlusion.Review of the history device records noted one nonconformity during products manufacturing.The affected pieces were scrapped.Based on evaluation of the devices, the reported issue could not be confirmed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.Refer mdr 1226348-2017-10765 for the report associated with the catheter attached to this valve, and mdrs 1226348-2017-10802 and 1226348-2017-10803 for the reports associated with the second valve and catheter set.

• Brand Name: HAKIM PROGRAMMABLE VALVE, RT ANGLE
• 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 Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6954731
• MDR Text Key: 89492210
• Report Number: 1226348-2017-10764
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 82-3184
• Device Lot Number: CVLCBC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2016
• 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