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

Catalog Number 82-3101

Device Problems Leak/Splash (1354); Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 11/06/2017

Event Type  Injury  

Manufacturer Narrative

Udi: product made prior to compliance date, gtin unavailable.It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.Device not available.

Event Description

It was reported that the shunt failure occurred after the reported device was implanted.Furthermore leakage occurred in the middle of the abdominal cavity catheter when contrast was conducted due to shunt failure, so it was scheduled the removal surgery.The patient¿s information is not available.No further information available.The product will not be returned to your site.

Manufacturer Narrative

It was previously reported that the device was not available for evaluation, however, the device was returned for evaluation.A follow up report will be filed upon completion of the investigation.

Manufacturer Narrative

Updated udi: product made prior to compliance date, (b)(4).Upon completion of the investigation it was noted that the images were taken of the ¿as received¿ valve.The position of the cam when valve was received was 30 mmh2o.The valve was visually inspected: a needle hole was noted in the silicone housing between the valve mechanism and the distal connector.The valve was hydrated.The valve was tested for programming with programmer 82-3126 with serial (b)(4), the valve passed the test.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested.No leaks noted.The catheter was irrigated, no occlusion noted.The valve was reflux tested.The valve passed the test.The valve was dried.The valve was then pressure tested, the valve passed the test.Review of the history device records confirmed the valve product code 82-3101, with lot ctmb95, conformed to the specifications when released to stock in 11th november 2015.No root cause could be determined; as no problem was noted with the valve.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 PROGRAMMABLE VALVE WIHOUT PRECHAMBER
• 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: 7074702
• MDR Text Key: 93458299
• Report Number: 1226348-2017-10906
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 82-3101
• Device Lot Number: CTMB95
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2015
• 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 Outcome(s): Required Intervention