MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR UNKNOWN CERTAS PLUS VALVE

Model Number 82-5473

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 06/23/2021

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 facility reported a codman hakim precision fixed pressure valve in-line valve was implanted in a patient on (b)(6) 2021.The facility reported fluid was tracking around the valve and the decision was made to tap the shunt.The site was prepped and draped in sterile fashion.A 23-gauge butterfly needle was inserted into the reservoir.There was an immediate return of clear cerebral spinal fluid, dripping briskly.The opening pressure was 6-7cm.With proximal portion occluded there was sluggish to no distal runoff.Subsequently, 25 milliliters of cerebral spinal fluid were withdrawn, after fontanelle was soft, slightly concave.The provider then attempted to flush distally.The patient was re-prepped and draped.A butterfly needle was inserted into the reservoir.There was again immediate return of clear cerebral spinal fluid, with an opening pressure of 4-5cm.With the occluded proximal catheter, 10 milliliters were flushed through the distal portion.With proximal portion occluded, no distal runoff, fluid column rose and bubbled over the end of the tubing.Proximal portion occluded; another 20 milliliters flushed distally.Again, noted to have brisk drainage when nothing occluded, when proximal portion occluded, fluid stopped draining and fluid column rose-up the tubing to the top.Findings were consistent with distal malfunction.The patient was taken to the operating room on (b)(6) 2021 for a shunt revision.

Manufacturer Narrative

Certas valve was not returned for evaluation after three good faith attempts (gfes) were made; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The root cause of the reported issue could not be determined.However, a probable root cause for the reported complaint could be due to biological debris and protein build up interfering with the device.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: UNKNOWN CERTAS PLUS VALVE
• Type of Device: CERTAS PLUS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12170783
• MDR Text Key: 267667730
• Report Number: 3013886523-2021-00304
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10886704042020
• UDI-Public: (01)10886704042020(17)240430(10)3838830
• Combination Product (y/n): N
• PMA/PMN Number: K041296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 82-5473
• Device Catalogue Number: XXX-CERTAS PLUS VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Date Device Manufactured: 05/24/2019
• 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