MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE CLYNDRICAL W PRECHA; CHPV

Catalog Number 823110

Device Problem Improper Flow or Infusion (2954)

Patient Problems Failure of Implant (1924); Ambulation Difficulties (2544)

Event Date 02/24/2021

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 facility reported a valve programming issue.The valve was implanted on (b)(6) 2021 to treat hydrocephalus.After implantation, pressure adjustment was required, and several attempts to change the setting were unsuccessful.However, on (b)(6), the patient was discharged from the hospital.On (b)(6) 2021, the patient's condition worsened and the patient was hospitalized again.The patient presented with decreased athletic ability and difficulty walking.When the cylinder was pressed without clogging, it is pumped and serves as a fixed setting value.On (b)(6) 2021 the physician tried to control at intervals with 2 programmer several times, but the pressure did not change.It was suspected valve defect and the valve was replaced.The patient recovered and was discharged.

Manufacturer Narrative

The valve was returned for evaluation: device history record (dhr) - the product code 823110 with lot 3945840 conformed to the specifications when released.Failure analysis - the valve was visually inspected; some needle holes were noted in the silicone housing.The position of the cam when valve was received was at 30mm h2o.The valve was hydrated.The valve was leak tested and only leaked from the needle hole in the silicone housing.The valve passed the test for programming, occlusion, reflux and pressure.The root cause for the needle holes found in the silicone housing could be due to a user error that punctured silicone housing instead of needle chamber.As noted in the ifu silicone has a low tear/cut resistance.Nevertheless, those needle holes did not have an impact on the functioning of the valve at the time of investigation.The possible root cause for the reported event "pressure did not change" could be due to biological debris and protein build up interfering with the valve mechanism, but at the time of investigation, no functional issues were noted.

Event Description

N/a.

• Brand Name: PROG VALVE CLYNDRICAL W PRECHA
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11573054
• MDR Text Key: 249757807
• Report Number: 3013886523-2021-00134
• Device Sequence Number: 1
• Product Code: JXG
• 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
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823110
• Device Lot Number: 3945840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1