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	07/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a hakim valve (id 823162) was implanted due to secondary normal pressure hydrocephalus (snph) 10 years ago via ventriculoperitoneal (v-p) shunt with unknown setting.Due to a suspicion of obstruction, the valve and catheter were removed and replaced on (b)(6) 2024.According to information provided, it is unknown if patient had any signs and symptoms due to valve obstruction.
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
N/a.
Additional Manufacturer Narrative
The hakim valve (id: 823162) was returned for evaluation.Device history record (dhr) - no discrepancies were noted for the products being accepted, they were released to stock.Failure analysis - the position of the cam when valve was received was on setting 90 mmh2o.The valve was visually inspected, leak from the ventricular connector and needle hole in the needle chamber were noted.The valve was hydrated.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 the needle hole.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, at the time of investigation no occlusion issue was noted.

• 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: 19838971
• Report Number: 3013886523-2024-00214
• Device Sequence Number: 20525266
• Product Code: JXG
• UDI-Device Identifier: 10886704041559
• UDI-Public: 10886704041559
• 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): 10/17/2024

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: 07/03/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown