MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CHPV WIDE INLINE SG; CHPV LOW PROFILE

Catalog Number 825422

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Failure of Implant (1924)

Event Date 04/21/2021

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 physician reported a hakim programmable valve was implanted to a patient via l-p shunt.When the outflow of cerebrospinal fluid from the abdominal cavity side was confirmed by valve pumping during the procedure, it was confirmed that the flow was very poor.The physician suspected that the lumbar catheter was obstructed, but when the physician disconnected it and confirmed the outflow of cerebrospinal fluid from the lumbar catheter again, the outflow of cerebrospinal fluid was possible.During the operation, contrast was performed to confirm that the lumbar catheter was placed in the lumbar subarachnoid space, and it was determined that the problem was a valve.Underdrainage was suspected, so the valve was replaced during the procedure.A surgical delay greater than 30 minutes reported.The patient is in the follow-up.

Event Description

N/a.

Manufacturer Narrative

The hakim valve was returned for evaluation.Failure analysis - the valve was visually inspected; no defects were noted.The position of the cam when valve was received was 70mmh2o.The valve was hydrated.The valve was leak tested and no leaks noted.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the problem reported by the customer could be due to an excessive flow rate (>0.75 ml/min) during the flushing procedure activates the siphon guard and creates the impression that the valve is distally occluded.In reality the flow is being diverted to the high resistance secondary pathway, this will slow the rate at which csf is shunted from the brain.It would probably explain the problem encountered by the customer.

• Brand Name: CHPV WIDE INLINE SG
• Type of Device: CHPV LOW PROFILE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• MDR Report Key: 11791136
• MDR Text Key: 250962098
• Report Number: 3013886523-2021-00211
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 825422
• Device Lot Number: 4499903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1