MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV ONLY W/SPHNGD; CERTAS PLUS W/ SG

Catalog Number 828804

Device Problem Improper Flow or Infusion (2954)

Patient Problem Injury (2348)

Event Date 12/28/2020

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported a functional issue with a shunt valve.A certas plus programmable inline valve was implanted in a patient via a ventricular peritoneal shunt on an unknown date in 2019 with an unknown initial setting.The valve was used with a ventricular catheter (823041) and a peritoneal catheter (823045).An xray was performed on an unknown date and cerebrospinal fluid was noted to be retained around the wound.The patient did not have clinical symptoms.The valve was removed on (b)(6) 2020.Replacement will be based on monitoring the patient's clinical condition over time.No further information was provided.

Manufacturer Narrative

Updated fields: d10, g4, g7,h2, h3, h6, h10 unique device identifier (udi) : (b)(4).The certas valve was returned for evaluation: failure analysis - the position of the cam when valve was received was at setting 8.The valve was visually inspected; the silicone housing was cut/torn around the siphon guard and needle holes in the needle chamber were noted.The valve was hydrated.The valve was flushed no occlusion was noted at the ruby ball but leaked from the cut/tear in the silicone housing around the siphon guard.The valve was leak tested and leaked from the cut/tear in the silicone housing around the siphon guard.The valve could not be reflux tested due to the cut/tear in the silicone housing around the siphon guard.The siphon guard was visually inspected marks were noted in the siphon guard.The valve passed the rest for programming, siphon guard and pressure.The root cause for the issue reported by the customer, "csf retention around wound was observed without clinical symptoms¿ was probably due to the cut/tear in the silicone housing.The root cause for the cut/tear in the silicone housing around the siphon guard was probably caused by a sharp or pointed object coming into contact with the silicone housing, as noted in the "ifu" silicone has a low cut/tear resistance.The root cause for the marks in the siphon guard were probably caused by a sharp or pointed object coming into contact with the siphon guard.

Event Description

N/a.

• Brand Name: CERTAS INLIN VLV ONLY W/SPHNGD
• Type of Device: CERTAS PLUS W/ SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11174405
• MDR Text Key: 227011524
• Report Number: 3013886523-2021-00022
• 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
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR