MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. CERTAS PLUS INLINE VALVE ONLY; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8800PL

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Information (3190)

Event Date 08/12/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Incident: pressure setting of 4 was selected.Pt op was 90-100.The valve was opened after valve confirmed at setting 4.Clinician flushed valve and catheter and felt a 'pop'.When he tested the valve w manometer fluid ran through valve slowing below 40mm.Checking again w manometer there was no slowing of fluid through the valve.It ran straight through.We did no feel comfortable implanting this valve due to questionable function.The second valve was set at 4, flushed and manometer tested.The fluid slowed between 110/120mm so this was working as intended and implanted.Same lot number.No injury, no case delay.

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 irrigated with purified water.No occlusion was noted.The valve was dried.The valve was leak tested, no leaks were noted.The valve was tested for programming.The valve passed the test.The valve was then pressure tested, the valve passed the test.Review of the history device records confirmed the valve product code 82-8800pl with lot cthcfh, conformed to the specifications when released to stock on the 3rd july 2015.No root cause could be determined as the problem reported by the customer was not confirmed.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: CERTAS PLUS INLINE VALVE ONLY
• 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: 5072202
• MDR Text Key: 25633572
• Report Number: 1226348-2015-10520
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK143111
• 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: Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 82-8800PL
• Device Lot Number: CTHCFH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2015
• 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