MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CHPV INLIN/SG INTEGRAL CON; CHPV WITH SG

Catalog Number	823842
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2024
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 (id 823842) was implanted via ventriculoperitoneal (vp) shunt on unknown date and setting due to unknown reason.The valve was removed due to an obstruction on an unknown date.After checking the valve, it was found that the proximal side of the connector was damaged.According to information provided, it is unknown if the device was replaced and what type of damage was found.It is also unknown if the patient experienced any signs and symptoms due to obstruction.
Additional Manufacturer Narrative
The hakim valve (id 823842) was returned for evaluation.Device history record (dhr) - the product code 82-3842 with lot cnpbfm, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; the proximal connector was detached from the valve and the stator was dislodged.It was not possible to test the valve as the proximal connector was missing and the stator was dislodged.Proximal connector and silicone housing where the connector should be attached were visually inspected no damage noted (possibly pulled out during ex-plantation of the valve).The catheters were irrigated, no occlusions noted.The valve was dismantled and was examined under microscope at appropriate magnification; corrosion was noted on the stator.The cam magnets were controlled and passes.Root cause analysis - the root cause for the issue reported by the customer could not be confirmed due to the damaged to the valve.The root cause for the dislodged stator noted during the investigation is due to the corrosion found on the stator.The root cause for the corrosion noted on the stator; the corrosion could not be clearly determined.Corrosion, when it arises, only arises after long term exposure to csf.The valve seems to have been implanted for some years.The root cause for the detached connector could be due to being pulled apart during explantation of the valve.

• Brand Name: CHPV INLIN/SG INTEGRAL CON
• 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: 19430630
• Report Number: 3013886523-2024-00156
• Device Sequence Number: 20867839
• Product Code: JXG
• UDI-Device Identifier: 10886704041856
• UDI-Public: (01)10886704041856(17)171231(10)CNPBFM
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/20/2024

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 Expiration Date: 12/31/2017
• Device Catalogue Number: 823842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2012
• 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 Sex: Unknown