MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. CERTAS INLINE VLV W/ SPHNGRD; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8805

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

Patient Problem No Information (3190)

Event Date 07/14/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Shunt valve couldn't be pressed efficiently.The pump didn't rise after pressing.There was a leakage at the end of the valve.

Manufacturer Narrative

(b)(4).It was not possible to investigate the complaint as no sample was returned for evaluation.Numerous attempts were made to recover the device, with no success.If the sample is returned in the future, this complaint will be re-opened and evaluated.Review of the history device records confirmed the valve product code 82-8805 with lot 129402, conformed to the specifications when released to stock on the 7th april 2017.

Manufacturer Narrative

It was previously reported that the device would not be returned for evaluation.The device was subsequently returned.This report has been updated to reflect the corrected information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Upon completion of the investigation it was noted that the position of the cam when valve was received was at setting 3.The valve was visually inspected; no defects were noted.The valve was hydrated.The valve was tested for programming.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 valve was reflux tested.The valve passed the test.The siphon guard was tested.The valve passed the test.The valve was dried.The siphon guard was removed.The valve was then pressure tested, the valve passed the test.Review of the history device records confirmed the valve product code 82-3114 with lot cklbmt, conformed to the specifications when released to stock on the 5th april 2017.No root cause could be determined as no functional problem was noted with the valves.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.

Manufacturer Narrative

The previously filed report listed an incorrect lot and product code combination for the dhr review.The report should have stated: "review of the history device records confirmed the valve product code 82-8805 with lot 129402, conformed to the specifications when released to stock on the 7th april 2017." this report has been updated to reflect the corrected information.At present, we consider this complaint to be closed.

• Brand Name: CERTAS INLINE VLV W/ SPHNGRD
• 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: 6758007
• MDR Text Key: 81594157
• Report Number: 1226348-2017-10533
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112156
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 82-8805
• Device Lot Number: 129402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2017
• 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