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

Model Number	82-3162
Medical Device Problem Codes	Obstruction of Flow (2423); Positioning Problem (3009)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2023
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
A facility reported a hakim valve was implanted via v-a shunt on (b)(6) 2020 with unknown setting.On unknown date, the set pressure could not be changed.No csf flow into the distal catheter was observed.Obstruction was suspected, therefore, the valve was removed and replaced on (b)(6) 2023.The patient's condition is stable.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim valve (id (b)(4)) was returned for evaluation.Device history record (dhr) - the product code (b)(4) with lot 3366699, conformed to the specifications when released to stock failure analysis - the valve was visually inspected: tears/cuts in the silicone housing were noted in the needle chamber and over the valve casing.The position of the cam when valve was received was 150mmh2o.The valve was hydrated.The valve was leak tested and failed, leaked from the damaged silicone housing.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.The valve casing was visually inspected, marks were noted in the valve casing.No root cause could be determined for the issue reported by the customer as the technician could not confirm any occlusions with the valve at the time of investigation.The possible root cause for the issue reported by the customer, could be due to the cuts / tears in the silicone housing, causing a leakage into unintended parts of the body.The root cause for the damaged silicone housing is due to a sharp or pointed object coming into contact with the silicone, as noted in the ifu silicone has a low cut/tear resistance.The root cause for the mark in the valve casing is due to a sharp or pointed object coming into contact with the valve casing.

• Brand Name: PROG VALVE INLINE W SG
• Common Device Name: CHPV WITH SG
• 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: 16241310
• Report Number: 3013886523-2023-00012
• Device Sequence Number: 17780311
• Product Code: JXG
• UDI-Device Identifier: 10886704041559
• UDI-Public: (01)10886704041559(17)231231(10)3366699
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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 Expiration Date: 12/31/2023
• Device Model Number: 82-3162
• Device Catalogue Number: 823162
• Device Lot Number: 3366699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2019
• 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
• Patient Age: 10 YR
• Patient Sex: Female