MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN CERTAS TOOL KIT; CERTAS PLUS PROGRAMMING REPLACEMENT PARTS

Catalog Number 828851

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product was received for evaluation: udi (b)(4).Dhr.There is no indication that the production process may have contributed to this complaint.Failure analysis.A small semicircular dent on the bottom edge of the housing was noted during the review.The unit failed the performance test in both the horizontal and vertical orientations.Root cause.It is likely that the inability of the programmer to adjust is due to the unit being dropped.Drop tests performed on this product have confirmed that the action of dropping the unit has a significant chance of damaging the pivots in the unit.

Event Description

A facility reported the certas tool kit was not readjusting the valve: the valve was implanted during (b)(6) 2018; and in (b)(6) 2019 a probable shunt dysfunction was discovered when the pump chamber was flat and the resistance was not able to be measured or be adjusted.During the examination of certas plus the product did not remove water.The patient suffered increased intra-cranial pressure and had to undergo shunt revision.

• Brand Name: CODMAN CERTAS TOOL KIT
• Type of Device: CERTAS PLUS PROGRAMMING REPLACEMENT PARTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 325 paramount drive; raynham, MA 02767 ; 6099362319
• MDR Report Key: 10281015
• MDR Text Key: 202705862
• Report Number: 1226348-2020-00398
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Date Manufacturer Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1