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

Model Number	82-3162
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a prog valve inline w sg (id 823162) was implanted via v-p shunt over 10 years ago with 110 mmh2o.The set pressure was not changed, therefore an attempt was made to change the set pressure from 110mm h2o to 90 mm h2o, however, it could not be changed.The valve was removed and replaced on (b)(6) 2022.Based on information provided, it is unknown if the patient experienced any signs and symptoms due to the issue.
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) - the product code 82-3162 with lot cmhcz6, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; needle holes in the needle chamber were noted.The position of the cam when valve was received was 120mmh2o.The valve was hydrated.The valve was tested for programming; the valve failed, the cam mechanism wriggled.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve was retested for programming and passed the test.The valve passed the test for occlusion, reflux, siphon guard and pressure.The valve was visually inspected under microscope at appropriate magnification: biological debris was found on the cam mechanism.The root cause for the issue reported by the customer, was due to biological debris and protein build up interfering with the valve mechanism.

• 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: 14497755
• Report Number: 3013886523-2022-00219
• Device Sequence Number: 14847596
• Product Code: JXG
• UDI-Device Identifier: 10886704041559
• UDI-Public: (01)10886704041559(17)160630(10)CMHCZ6
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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): 07/13/2022

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: 06/30/2016
• Device Model Number: 82-3162
• 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): Follow-Up
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2011
• 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