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

Catalog Number 82-8805

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

(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, after a year, a certas plus valve was suspected of being obstructed and was revised.The product will be returned.

Manufacturer Narrative

Additional information: the device was returned for evaluation.The position of the cam when the valve was received was at setting 3.The valve was visually inspected; needle holes in the needle chamber were noted.The valve was tested for programming and passed.The valve was flushed; no occlusions were noted.The valve was leak tested; only leaked from the needle holes in the needle chamber.The catheter was irrigated no occlusions noted.The valve was reflux tested and passed the test.The siphon guard was tested and passed.The valve was dried.The siphon guard was removed.The valve was then pressure tested and passed.A search for relative complaint for the same issue with the same product code and lot number was not possible as the lot number was unknown.Review of the history device records was not possible as the lot number was unknown.Based on the results of the investigation, the reported issue could not be confirmed.The device functioned as intended.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: 8095141
• MDR Text Key: 128079625
• Report Number: 1226348-2018-10822
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 82-8805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention