MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. CERTAS PLUS INLINE WITH SIPHONGUARD VALVE 120CM UNITIZED BACTISEAL DISTAL CATH; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8807PL

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

I received this picture from one of my surgeons today.This is a certas plus valve that was implanted approximately a month and a half ago that just recently had to undergo a revision.As you can tell by the picture it basically "ruptured" at the siphon guard connection to the valve mechanism housing.

Manufacturer Narrative

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

• Brand Name: CERTAS PLUS INLINE WITH SIPHONGUARD VALVE 120CM UNITIZED BACTISEAL DISTAL CATH
• 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: 4935463
• MDR Text Key: 6034957
• Report Number: 1226348-2015-10418
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112156
• 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: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 82-8807PL
• Device Lot Number: CTCCTG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2015
• 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
• Patient Outcome(s): Required Intervention