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

Catalog Number 82-3136

Device Problem Flushing Problem (1252)

Patient Problem No Information (3190)

Event Date 12/16/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Tried to flush valve and resisted and wouldn't flush.Surgeon opened new valve to complete.Event occurred prior to surgery and caused no delays.(b)(6) 2016 per phone conversation, alert date is (b)(6) 2016.

Manufacturer Narrative

Upon completion of the investigation, it was noted that the position of the cam when valve was received was 110mmh2o.The valve was visually inspected: no defects were noted.The valve was irrigated with purified water, no occlusion was noted.The siphon guard was irrigated with purified water, no occlusion was noted.The catheter was irrigated with purified water, no occlusion was noted.It is possible that too much pressure was applied when flushing the device.Review of the history device records confirmed the valve product code 82-3136 with lot ctbcc8, conformed to the specifications when released to stock on the 27th february 2015.No root cause could be determined as the problem reported by the customer was not confirmed.The problem was likely due to an excessive flow rate (>0.75 ml/min) during the flushing procedure activates, the siphon guard and creates the impression that the valve is distally occluded.In reality the flow is being diverted to the high resistance secondary pathway, this will slow the rate at which csf is shunted from the brain.It would probably explain the problem encountered by the customer.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time, this complaint is closed.

• Brand Name: HAKIM PROG VALVE, RT ANGLE RES. SEPARABLE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; ch-2400 le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5380902
• MDR Text Key: 36471059
• Report Number: 1226348-2016-10063
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK992173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 82-3136
• Device Lot Number: CTBCC8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2015
• 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 Age: 39 YR