MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMABLE VALVE; CHPV

Catalog Number 823100

Device Problem Pressure Problem (3012)

Patient Problem Failure of Implant (1924)

Event Date 06/10/2021

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 codman hakim programmable valve was implanted in a patient via a ventricular peritoneal shunt about 10 years ago with an unknown initial setting.The set pressure of the valve could not be changed on (b)(6) 2021.It is unknown if the patient presented with clinical signs and symptoms.The patient was taken to the operating room on (b)(6) 2021 for a shunt revision and the valve was removed and replaced.The patient is in follow up.

Manufacturer Narrative

Updated fields: d1,d2,d3,d4, d9, g3, g6, h2, h3, h6, h10 the hakim valve was returned for evaluation.Device history record (dhr) - the lot history record was reviewed for completeness during the release process to inventory.At that time based on the fact that no discrepancies were noted for the products being accepted, the device with serial number (b)(6), product code 82-3100, was released to stock failure analysis - the valve was visually inspected; no defects were noted.The position of the cam when valve was received was 40mmh2o.The valve was hydrated.The catheter was irrigated no occlusion was noted.The valve was leak tested and no leaks noted.The valve passed the test for programming, occlusion, reflux 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 issue reported by the customer, could be due to biological debris and protein build up interfering with the valve mechanism, at the time of investigation no programing issue was noted.

Event Description

N/a.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle MA ; SZ
• MDR Report Key: 12116213
• MDR Text Key: 260242051
• Report Number: 3013886523-2021-00290
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823100
• Device Lot Number: PJ2093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1