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

Catalog Number 82-8804

Device Problems Partial Blockage (1065); Insufficient Flow or Under Infusion (2182); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The reported valve was implanted to the patient via vp-shunt on (b)(6) 2017 (the initial setting was setting 4).However, the catheter at the ventricle side was dislocated and a surgery was performed to relocate the catheter to the desired position at the beginning of feb.The patient¿s condition didn¿t improve, so the pressure setting was changed from setting 4 to setting 3, but the condition stayed the same.A contrast examination was performed and it was noted that the flow of csf was little and the valve blockage was suspected.The valve was removed from the patient¿s body on (b)(6) 2017 (the final setting was setting 3).Alternative valve, medtronic strata was used for revision.The patient¿s current condition is good.The patient is a (b)(6) male, and was suffered from sah.The surgeon commented that the valve might be blocked by something when the relocation surgery was performed.There is no further information provided by the hospital.

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: needle holes in the needle chamber were noted.The valve was hydrated for 24 hours.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, only leaked from the needle holes in the needle chamber.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 was not possible as the lot numbers are unknown.No root cause could be determined, as the problem reported by the customer could not be duplicated, the valve functions.If the catheter is returned in the future, this complaint will be re-opened and the catheter investigated.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 INLIN VLV ONLY W/SPHNGD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6364167
• MDR Text Key: 68500846
• Report Number: 1226348-2017-10128
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-8804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 62 YR