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

Model Number	82-5473
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/23/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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portion occluded there was sluggish to no distal runoff.Subsequently, 25 milliliters of cerebral spinal fluid were withdrawn, after fontanelle was soft, slightly concave.The provider then attempted to flush distally.The patient was re-prepped and draped.A butterfly needle was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.
Additional 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 or Problem Description
N/a.

• Brand Name: UNKNOWN CERTAS PLUS VALVE
• Common Device Name: 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
• Report Number: 3013886523-2021-00304
• Device Sequence Number: 1492898
• Product Code: JXG
• UDI-Device Identifier: 10886704042020
• UDI-Public: (01)10886704042020(17)240430(10)3838830
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 04/04/2022
• Date Device Manufactured: 05/24/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown