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

Catalog Number	823162
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve (id 823162) was implanted on (b)(6) 2024.After the procedure, the hydrocephalus of the patient didn't improve.On (b)(6) 2024, the physician conducted the revision procedure and found that the valve was broken.Therefore, the valve was removed and replaced.After the procedure, the patient felt better and discharged from the hospital on (b)(6) 2024.
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
Additional information received.The valve was removed and replaced on (b)(6) 2024.All broken parts were recovered.There is no information available on whether the patient experienced any signs or symptoms due to the device issue.It is unknown if an x-ray was taken to assure that no broken parts left in the patient.
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 6987042, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 40 mmh2o.The valve was visually inspected; the siphon guard was broken.Cut and tear mark were noted on the siphon guard and housing.The complaint was confirmed root cause analysis - the root cause for the issue reported by the customer could be due to a sharp or pointed object coming into contact with the valve or atypical handling, as noted in the surgical procedure precautions section in instruction 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 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20472665
• Report Number: 3013886523-2024-00321
• Device Sequence Number: 17949074
• Product Code: JXG
• UDI-Device Identifier: 10381780519232
• UDI-Public: (01)10381780519232(17)271231(10)6987042
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 823162
• Device Lot Number: 6987042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2024
• Supplement Date Received by Manufacturer: 10/22/2024; 02/03/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/07/2024; 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian