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

Catalog Number	823162
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	02/06/2024
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 physician reported a hakim valve (b)(6) was implanted in a female patient due to congenital hydrocephalus via ventriculoatrial shunt on (b)(6) 2023, with a set pressure of 160mmh²o.The patient was discharged from the hospital in late january.During the outpatient visit in early february, it was confirmed that hydrocephalus was progressing and cerebrospinal fluid (csf) was leaking from surgical wound.An attempt was made to change the pressure of the valve using a high power magnet however, the hakim programmer failed.There was a suspicion of obstruction therefore, the valve, peritoneal catheter, and ventricular catheter were removed on (b)(6) 2024.When extracting, the surgeon noticed the damage in silicone housing of the valve.The patient is on external drainage.She had fever with antibiotic treatment.The patient is on follow-up and v-a shunt will be performed after 2 to 3 weeks.
Additional Manufacturer Narrative
The hakim valve (id 823162) was returned for evaluation.Device history record (dhr) - the product code 82-3162 with lot 7274169, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 160 mmh2o.The valve was visually inspected, a tear/cut in the silicone housing was noted along the siphon guard and over the valve casing.The valve was hydrated.The valve failed the test for programming.Flush, leak, reflux and siphon guard tests could not be performed as the siphon guard was damaged.The pressure test could not be performed as the device could not be programed.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification: biological debris were found on the ruby ball, on the seat of the ruby ball and motor.A visual control magnetizing engines was performed; a normal polarization was noted.Root cause analysis - the possible root cause for the issue reported by the customer, is due to biological debris and protein build up interfering with the valve in view of the biological debris found during the investigation.The root cause for the ¿siphon guard damaged¿ due a sharp or pointed object coming into contact with the valve or atypical handling, as noted in the surgical procedure precautions section in instructions for use (ifu), silicone has a low cut/tear resistance.
Event or Problem Description
N/a.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18743588
• Report Number: 3013886523-2024-00043
• Device Sequence Number: 6380303
• Product Code: JXG
• UDI-Device Identifier: 10381780519232
• UDI-Public: (01)10381780519232(17)280630(10)7274169
• 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: 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): 04/11/2024

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: 823162
• Device Lot Number: 7274169
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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: 38 YR
• Patient Sex: Female