MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3832

Device Problem Obstruction of Flow (2423)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that the hakim valve was blocked, the patient had neurologic deficits and the device was revised.The valve was implanted to the patient via vp-shunt due to communicating hydrocephalus, initial setting is unknown.The patient became hindered of consciousness and was temporarily hospitalized.The valve was checked with contrast and it was found that it was not flowing to the distal side.The flow was confirmed to the ventricle catheter side.The removal surgery was performed and evt was performed.The patient recovered.The surgeon asked if the valve incompletely blocked , it flows a little when the pressure setting was reduced.It was suspected of blood and debris contamination in the cerebrospinal fluid.No further information was provided by hospital.The product will be returned to your site.

Manufacturer Narrative

The valve was returned for evaluation.The position of the cam when valve was received was 140mmh2o.The valve was visually inspected: needle holes in the needle chamber were noted.The valve was tested for programming and passed.The valve was flushed; no occlusion was noted.The valve was leak tested, reflux tested and pressure tested; no issues found.A review of manufacturing record found no discrepancies when the device was released to stock.Based on the results of the investigation, the reported issue could not be confirmed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD
• 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
• MDR Report Key: 7440548
• MDR Text Key: 105838536
• Report Number: 1226348-2018-10284
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K992173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 82-3832
• Device Lot Number: CVHBDZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 16 YR