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

Model Number 823111

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

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 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
• Type of Device: CHPV
• 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: 11510112
• MDR Text Key: 240613342
• Report Number: 3013886523-2021-00119
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780519140
• UDI-Public: (01)10381780519140(17)250531(10)4772338
• Combination Product (y/n): N
• PMA/PMN Number: K122118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1