MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD STD CHPV W PRECHAMBER UNITIZED

Model Number	823111
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The valve was received for evaluation: dhr - lot number 4772338, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; the stator was dislodged and a mark and crack in valve casing was noted.The valve passed the tests for occlusion, leak and magnets.The valve was reflux tested; failed due to the dislodged stator.The valve was dismantled and examined under microscope at appropriate magnification: a bump mark and cracks were noted in the valve casing.The root cause for the issue reported by the customer (a "wheel "on shunt is defective) is linked to the dislodged stator.The root cause for the dislodged stator is due to the valve receiving a hard knock.The root cause for the bump mark and cracks in the valve casing is due to the valve receiving a hard knock.
Event or Problem Description
A facility reported a hakim valve with a defective "wheel ".The patient had a revision surgery to replace the valve.

• Brand Name: STD CHPV W PRECHAMBER UNITIZED
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• MDR Report Key: 11510112
• Report Number: 3013886523-2021-00119
• Device Sequence Number: 4075595
• Product Code: JXG
• UDI-Device Identifier: 10381780519140
• UDI-Public: (01)10381780519140(17)250531(10)4772338
• Combination Product (Y/N): N
• PMA/510(K) Number: K122118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2021

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: 05/31/2025
• Device Model Number: 823111
• Device Catalogue Number: 823111
• Device Lot Number: 4772338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1