MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MICRO CHPV UNITIZED

Model Number 82-3114

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

A facility reported a hakim valve (id 823114) stopped working during surgery and it was replaced.The event led to 1 hour surgical delay.No patient injury reported.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The hakim valve was returned for evaluation: dhr - lot 123637, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; no defects noted.The valve passed the tests for programming, occlusion, leaks, reflux and pressure root cause - no root cause could be determined as the technician could not confirm any problems with the valve at the time of investigation.The possible root cause for the issue reported by the customer, could be due to valve not set a correct pressure.Setting for patients condition.At the time of the investigation no functional issues were noted with the valve.Additional information received: date of implantation: (b)(6) 2017; date of explantation: (b)(6) 2022."the patient came with problems of overdrainage: headache during mobilization, rather no underdrainage.In this respect, there was a suspicion that the valve was allowing csf to pass uncontrollably and therefore overdrainage.After implantation of an adult valve on (b)(6) 2022 the problems disappeared, the patient is well again.".

Event Description

N/a.

• Brand Name: MICRO CHPV 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: 14685085
• MDR Text Key: 294882054
• Report Number: 3013886523-2022-00265
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10886704041498
• UDI-Public: (01)10886704041498(17)220228(10)123637
• Combination Product (y/n): N
• PMA/PMN Number: K053107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 82-3114
• Device Catalogue Number: 823114
• Device Lot Number: 123637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2017
• 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