MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CHPV RT ANG RES W SG UNITIZED; CHPV WITH SG

Catalog Number	823146
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hakim valve (id 823182) was returned for evaluation.Device history record (dhr) - the product code 82-3146 with lot cphbkm, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 60 mmh2o.The valve was visually inspected, needle hole in the needle chamber was noted.Bump mark was noted on the cam.The valve was hydrated.The catheter was irrigated, and no occlusion noted.The valve passed the test for occlusion, reflux and siphon guard.The valve failed the test for programming and pressure.The valve was leak tested and passed, only leak from needle hole.The valve was disassembled.The pressure test could not be performed because the device could not be programmed.The valve was visually inspected under microscope at appropriate magnification, a bump is visible on the casing, the cam is slanted, it is not in its initial position.Root cause analysis - the root cause of the "broken" issue reported by the customer was due to the patient's fall incident which caused damage to the cam.
Event or Problem Description
A physician reported a hakim valve (id 823182) was implanted due to unknown reason via ventriculoperitoneal (vp) shunt on unknown date with unknown setting.The device broke due to patient fall.Therefore, the valve was removed and replaced on unknown date.According to information provided, it is unknown how the valve failure was discovered.It is also unknown if the patient experienced any signs and symptoms due to product failure, and if x-ray taken to assure no parts left in patient.Current status of the patient is unknown.
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.

• Brand Name: CHPV RT ANG RES W SG UNITIZED
• 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: 19539032
• Report Number: 3013886523-2024-00172
• Device Sequence Number: 20416412
• Product Code: JXG
• UDI-Device Identifier: 10886704041535
• UDI-Public: (01)10886704041535(17)180531(10)
• 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: 05/31/2018
• Device Catalogue Number: 823146
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2013
• 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