MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE RIGHT ANGLE; CHPV

Catalog Number	823184
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2023
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
1 of 2 reports.Other mfg report number: 3013886523-2023-00243.A facility reported a hakim valve (id 823184) and a bactiseal ventricular catheter (id 23073) were implanted via ventricular peritoneal (vp) shunt on (b)(6) 2023.On (b)(6) 2023 the valve appeared to be occluded while the proximal catheter has a visible flow; therefore, the valve and catheter were removed and replaced on (b)(6) 2023.According to information provided, there was no known issue with the catheter however, the ventricular catheter was replaced.It is also unknown if the patient experienced any signs and symptoms due to valve malfunction.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6 & h10.The hakim valve (id 823184) was returned for evaluation.Device history record (dhr)- the product code 82-3184 with lot 6366268, conformed to the specifications when released to stock.Failure analysis: the position of the cam when valve was received was on setting 70 mmh2o.The valve was visually inspected; no defect was noted.The valve was hydrated.The valve passed the test for programming, occlusion, leaks, reflux and pressure.The valve functions.Root cause- no root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.However, 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.
Event or Problem Description
N/a.

• Brand Name: PROG VALVE RIGHT ANGLE
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17406560
• Report Number: 3013886523-2023-00233
• Device Sequence Number: 5837729
• Product Code: JXG
• UDI-Device Identifier: 10381780519263
• UDI-Public: (01)10381780519263(17)270430(10)6366268
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 08/10/2023

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 Catalogue Number: 823184
• Device Lot Number: 6366268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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
• Patient Sex: Unknown