MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE; CHPV

Model Number 823164

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 05/26/2022

Event Type  Injury  

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 Description

A physician reported a hakim valve (id 823164) was implanted via v-p shunt on unknown date with unknown settings to treat a midline fissure cyst.A catheter coming from the epidural and a catheter coming from the ventricle were connected with a y-shaped connector and connected to the valve.An obstruction was suspected therefore, the valve was removed and replaced on (b)(6) 2022.Based on information provided, it is unknown if the patient experienced any signs and symptoms.

Manufacturer Narrative

The hakim valve (id 823164) was returned for evaluation.Device history record (dhr) - the product code 82-3164 with lot 4755622, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; a needle hole in the needle chamber was noted.The position of the cam when valve was received was 70mmh2o.The valve was hydrated.The valve was tested for programming and failed, the cam mechanism wriggled.The valve was leak tested and only leaked from the needle hole.The valve passed the test for occlusion, reflux and pressure.The cam mechanism was gently moved, and the valve was retested for programming: fail, the cam mechanism wriggled.The valve was dismantled and was examined under microscope at appropriate magnification: some biological debris was noted on the cam mechanism.The cam magnets were controlled and failed.The root cause reported by the customer could not be determined as the technician could not confirm any occlusion problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the valve mechanism.The root cause for the programming issue was due to biological debris and protein build up found on the spring, on the cam mechanism, and on the ruby ball.The root cause for the abnormal polarization was probably caused by an exposition of a too strong magnetic field, as noted in the "ifu", ¿any magnet may experience a degradation of magnetic field strength as a consequence of exposure to the significantly stronger magnet field induced in a mri procedure.

Event Description

N/a.

• Brand Name: PROG VALVE INLINE
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14687893
• MDR Text Key: 294782415
• Report Number: 3013886523-2022-00266
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780519249
• UDI-Public: (01)10381780519249(17)250531(10)4755622
• Combination Product (y/n): N
• PMA/PMN Number: K041296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

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 Model Number: 823164
• Device Catalogue Number: 823164
• Device Lot Number: 4755622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2020
• 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
• Patient Age: 1 YR
• Patient Sex: Female