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

Catalog Number	823162
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/05/2024
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 physician reported a hakim valve (id 823162) was implanted via ventriculoperitoneal (vp) shunt on unknown date with unknown setting due to congenital hydrocephalus.Due to suspicion of obstruction, the valve was removed on (b)(6) 2024 and was replaced with another valve on an unknown date.Primary disease is meningitis.The patient is in follow up.Based on information provided, it is unknown if the patient experienced any signs and symptoms due to obstruction.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id 823162) was returned for evaluation.Device history record (dhr) ¿ the product code 82-3162 with lot 6331804, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 40 mmh2o.The valve was visually inspected; a tear mark was noted in the needle chamber.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.Root cause analysis - 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 ¿tear mark¿ could be due a sharp or pointed object coming into contact with the valve in view of the tear mark on the needle chamber.As noted in the surgical procedure precautions section in instruction for use (ifu), silicone has a low cut/tear resistance.
Event or Problem Description
N/a.

• 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: 19621044
• Report Number: 3013886523-2024-00190
• Device Sequence Number: 15484253
• Product Code: JXG
• UDI-Device Identifier: 10381780519232
• UDI-Public: (01)10381780519232(17)270331(10)6331804
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: 823162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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: 8 MO
• Patient Sex: Male