MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL SG VLV W CATH ACC; CERTAS PLUS SMALL & RA W/SG

Catalog Number 828815PL

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Injury (2348)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported that the certas valve was implanted to a (b)(6) old female patient on (b)(6) 2020.Three months post operative the patient returned to the hospital because a pseudomeningocele was developing around the implant site and was sent for a ct.The ct indicated fluid collection and a potential distal catheter disconnection.The patient was taken to the or for a revision.When the site was examined, the surgeon discovered that the housing of the valve had split at the point where the siphonguard connects to the valve housing.The distal catheter was connected and intact.The valve was then replaced, and surgery was completed.The patient was transferred to the floor and released.The patient is currently stable.

Manufacturer Narrative

Updated fields: d10, g4, g7,h2, h3, h6, h10.The valve was returned for evaluation.Failure analysis the valve was visually inspected; a cut/tear was noted in the silicone housing around the siphon guard complaint confirmed.The siphon guard was visually inspected and marks were noted in the siphon guard.The root cause for the housing of the valve had split at the point where the siphonguard connects to the valve reported by the customer is due to 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 found in the siphon guard would be due to a sharp or pointed object coming into contact with the siphon guard.

• Brand Name: CRTS SM IL SG VLV W CATH ACC
• Type of Device: CERTAS PLUS SMALL & RA W/SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10841098
• MDR Text Key: 216315548
• Report Number: 3013886523-2020-00195
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828815PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 MO