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

Catalog Number 823162

Device Problem Infusion or Flow Problem (2964)

Patient Problem Failure of Implant (1924)

Event Date 06/21/2021

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 codman hakim valve was implanted in a patient via a ventricular peritoneal shunt on (b)(6) 2021 for a primary diagnosis of spinal meningocele with an initial setting of 80 mmh20.As the head circumference became larger, the set pressure was lowered to 50 mmh2o on (b)(6)2021 and 30 mmh2o on (b)(6), 2021.The patient was taken to the operating room for a shunt revision where the valve was removed and replaced on (b)(6) 2021.It was reported when the abdominal cavity catheter of the removed valve was cut, there was no dripping.The patient is currently in follow-up.No further information was provided by the hospital.

Event Description

N/a.

Manufacturer Narrative

The codman hakim valve was returned for evaluation.Device history record (dhr) - the product code 823162 with lot 4175406 conformed to the specifications when released to stock.Failure analysis -the valve was visually inspected; needle holes in the needle chamber were noted.The position of the cam when valve was received was 40mmh2o.The valve was hydrated.The valve was leak tested and only leaked from the needle hole in the needle chamber.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 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 functional issues were noted.

• Brand Name: PROG VALVE INLINE W SG
• Type of Device: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 12140430
• MDR Text Key: 266209353
• Report Number: 3013886523-2021-00298
• Device Sequence Number: 1
• Product Code: JXG
• 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
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 MO