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

Catalog Number 82-8806

Device Problems Material Rupture (1546); Obstruction of Flow (2423)

Patient Problem No Information (3190)

Event Date 09/13/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The valve was implanted to the patient via lp-shunt.Doi was unknown and with initial setting 4.After a few day, ventricular enlargement was observed.The pressure setting was reduced but the issue continued.Obstruction was suspected and reoperation was performed on (b)(6) during the procedure, it was found that the valve and the sg were ruptured.Therefore, the valve was explanted and implanted a new one.The product will be returned to your site.

Manufacturer Narrative

The valve was returned for evaluation.The position of the cam when valve was received was at setting 1.The valve was visually inspected: the housing was torn at the level of the siphonguard.The valve was tested for programming according and passed.The valve was flushed, no occlusion was noted.The valve was not reflux and leak tested as the housing was torn.The siphon guard was removed.No issues were found with the siphonguard.The valve was then pressure tested and passed the test.Review of the history device records was not possible as the lot number is unknown.The root cause of the occlusion suspected by the customer was not identified as no occlusion was found during the investigation.The root cause for the tear/cut in the silicone housing is probably due to the user.As noted in the ifu silicone has a low tear / cut resistance.Through a previous investigation, it was concluded that silicone housing tears are not design related, in order for the housing tear to occur the user has to compromise the silicone through a nick or tear in order for the event to occur.Validation testing demonstrates a robust design.Testing has shown that if the silicone housing has been compromised, a housing tear is likely to occur.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: CERTAS INLIN VLV SPHN/UNIT CAT
• 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: 6936088
• MDR Text Key: 89170177
• Report Number: 1226348-2017-10746
• 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: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-8806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2017
• 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