MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MICRO CHPV W RICKHAM UNITIZED

Catalog Number	823113
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	08/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a hakim valve (id 823113) was implanted via ventriculoperitoneal shunt in (b)(6) 2008 with unknown setting.On unknown date, the patient came to the hospital for a routine check-up.X-rays were performed and ventricular enlargement was observed.An attempt was made to change the set pressure with a powerful magnet, but the change was unsuccessful.The patient had no clinical symptoms, but as a precaution, a revision surgery was performed for future management.The valve was removed and replaced on (b)(6), 2023.The patient recovered.
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.
Additional Manufacturer Narrative
The hakim valve (id 823113) was returned for evaluation.Device history record (dhr)- product code 82-3113 with lot cjdc56, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 7.The valve was visually inspected; the distal connector was dislodged.The valve was hydrated.The valve was tested for programming and failed.The tests for flush, leak and pressure could not be performed as the distal connector was dislodged.The valve passed the test for reflux.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification: biological debris was found on the ruby ball, motor and on the seat of the ruby ball.The valve was visually inspected magnetizing engines tested, passed.The complaint was confirmed.Root cause analysis- the root cause for the issue reported by the customer is due to biological debris and protein build up interfering with the valve, at the time of investigation biological debris were noted.The root cause for the pressure issue noted during the investigation is due to biological debris found on the ruby ball and on the cam / ball arm assembly as well as the rc, the debris was stopping the ruby ball from being seated correctly.
Event or Problem Description
N/a.

• Brand Name: MICRO CHPV W RICKHAM UNITIZED
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; ch-2400; mansfield MA ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17650869
• Report Number: 3013886523-2023-00291
• Device Sequence Number: 6285705
• Product Code: JXG
• UDI-Device Identifier: 10886704041481
• UDI-Public: (01)10886704041481(17)130430(10)CJDC56
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2023
• 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): 11/03/2023

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: 04/30/2013
• Device Catalogue Number: 823113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2008
• 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: 16 YR
• Patient Sex: Male