MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CERTAS INLINE VLV W/ SPHNGRD; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8805

Device Problem Separation Failure (2547)

Patient Problem Failure of Implant (1924)

Event Date 12/14/2018

Event Type  Injury  

Manufacturer Narrative

Udi -- (b)(4).The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the affiliate, 2 months after implant, the patient suffered a fall, x-rays showed that a certas plus valve was leaking from the distal end and was revised.The surgeon commented that the valve seemed to be damaged, that its siphonguard came out when the patient fell.The product will be returned.There were no reports of delays or patient harm.

Manufacturer Narrative

Additional information: the device was returned for evaluation.The valve was visually inspected: the silicone housing was damaged around the siphon guard.A review of manufacturing records was not possible, as not lot number was provided.Based on the results of the investigation, the reported issue was confirmed.The fall reported by the patient likely contributed to the reported issue.As noted in the ifu silicone has a low cut/tear resistance, and a hard knock could split the silicone housing.Trends will be monitored for this and similar issues.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): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle CH 24 00; SZ CH 2400
• MDR Report Key: 8249267
• MDR Text Key: 133109159
• Report Number: 1226348-2019-10044
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K152152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-8805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Date Manufacturer Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR