MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT; CERTAS PLUS W/ SG

Catalog Number 828806

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2021

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 underdrainage of a shunt valve.A certas valve was implanted in a patient via ventricular peritoneal shunt on (b)(6) 2021.During the surgical procedure, the valve was pumped to check for patency, but the flow rate was reportedly unstable.The physician used another product in which they could do the pumping without problems.No information of surgical delay was available from the hospital.

Event Description

N/a.

Manufacturer Narrative

The valve was returned for evaluation.Review of the history device records for the product code 82-8806 with lot number 4739009, conformed to the specifications when released to stock failure analysis - the position of the cam when valve was received was at setting 3.The valve was visually inspected; no defects were noted.The valve was hydrated.No leaks noted.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be due to after steam sterilization the ruby ball sticks to the ruby seat¿ and potential effects of failure include ¿'excessive pressure required to flush the valve pre-procedure ("valve popping").

• Brand Name: CERTAS INLIN VLV SPHN/UNIT CAT
• 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: 11373846
• MDR Text Key: 233342775
• Report Number: 3013886523-2021-00088
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 828806
• Device Lot Number: 4739009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1