MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD STD CHPV W PRECHAMBER UNITIZED

Catalog Number	823111
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Confusion/ Disorientation (2553)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve (id 823111) was not draining properly.The patient was disoriented and unable to walk; therefore, the valve was explanted and replaced with a competitors valve.When surgeon explanted it appeared to be bent.
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
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id 823111) was returned for evaluation.Device history record (dhr) - the product code 82-3111 with lot 4323031, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; no defects were noted.It was observed that the distal catheter was slightly out of line.The position of the cam when valve was received was 30mmh2o.The valve was hydrated.The valve passed the test for programming, occlusion, leak, reflux and pressure.Root cause analysis - no root cause could be determined for the issue reported by the customer as the technician could not confirm any problems with the valve at the time of investigation.A possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the device.At the time of investigation, no functional issues were noted with the valve.No root cause could be determined for the issue reported by the customer as seen in the investigation this does not have an impact on the functioning of the device, this is a cosmetic issue without impact.
Event or Problem Description
N/a.

• Brand Name: STD CHPV W PRECHAMBER UNITIZED
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19590355
• Report Number: 3013886523-2024-00177
• Device Sequence Number: 16982713
• Product Code: JXG
• UDI-Device Identifier: 10886704041467
• UDI-Public: (01)10886704041467(17)241130(10)4323031
• Combination Product (Y/N): N
• PMA/510(K) Number: K122118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Catalogue Number: 823111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male