MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD HAKIM PREC VALV W/PC - LO; PRECISION

Catalog Number	823012
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve was implanted on (b)(6) 2021.The patient had revision surgery twice on (b)(6) 2023 and (b)(6) 2023.Due to suspected occlusion of the sp shunt, an attempt to change the setting was performed but was unable to change and subdural space did not become smaller.Therefore, the valve was removed on (b)(6) 2023, and a 30 minute delay was noted.Protein concentration: 156.The patient primary disease is suspected interhemispheric fissure cyst.The patient recovered.
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.
Additional Manufacturer Narrative
Hakim valve (id 823012) was returned for evaluation.Device history record (dhr) - the product code 82-3012 with lot 3240380, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; a cut in the housing was noted.The valve passed the test for occlusion leaks, and pressure.Only leak from the cut in the housing.The valve failed the test for reflux.Root cause analysis - no occlusions issues were noted.The possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the valve.The root cause for the ¿cut in the housing¿ is due a sharp or pointed object coming into contact with the valve.As noted in the surgical procedure precautions section in ifu (instructions for use), silicone has a low cut/tear resistance.

• Brand Name: HAKIM PREC VALV W/PC - LO
• Common Device Name: PRECISION
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18159898
• Report Number: 3013886523-2023-00384
• Device Sequence Number: 12378730
• Product Code: JXG
• UDI-Device Identifier: 10886704041061
• UDI-Public: (01)10886704041061(17)230930(10)3240380
• Combination Product (Y/N): N
• PMA/510(K) Number: K122118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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: 09/30/2023
• Device Catalogue Number: 823012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 12/29/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2018
• 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 Age: 29 MO
• Patient Sex: Female