MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE INLINE W SG; CHPV WITH SG

Catalog Number	823832
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Headache (1880)
Date of Event	12/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve (id (b)(4) was implanted via ventriculoperitoneal (vp) shunt on (b)(6) 2023, due to high icp of 350mm/h2o and ventriculomegaly.After the procedure the patient was not feeling well.Therefore, the physician adjusted the pressure to 200mm/h2o and the patient was discharged.The pressure setting recorded on (b)(6) 2023, was 110mm/h2o after an x-ray was taken, however, on the following day, (b)(6) 2023, the patient's lumbar puncture pressure was 60mm/h2o only.The valve pressure was readjusted to 180 mm/h20 under x-ray on (b)(6) 2024.The patient was not willing to have an x-ray recheck despite the unclear result on the x-ray.The patient received a transfusion for a week and the lumbar puncture pressure of patient remained 60mm/h2o.The patient had a lumbar puncture pressure of 0mm/h2o on (b)(6) 2023.The patient experienced a headache due to a valve issue.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The hakim valve (id (b)(4) was returned for evaluation.Device history record (dhr) ¿ the product code 82-3832 with lot 5991688, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 30 mmh2o.The valve was hydrated; a needle hole in the needle chamber was noted.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.The valve was leak tested; no leak was noted, only leak from needle hole.Root cause analysis - no root cause could be determined as the technician could not confirm any problem 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 valve.

• Brand Name: PROG VALVE INLINE W SG
• Common Device Name: CHPV WITH SG
• 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: 19282313
• Report Number: 3013886523-2024-00135
• Device Sequence Number: 18036572
• Product Code: JXG
• UDI-Device Identifier: 10381780519805
• UDI-Public: (01)10381780519805(17)260130(10)5991688
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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 Catalogue Number: 823832
• Device Lot Number: 5991688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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 Age: 29 YR
• Patient Sex: Male