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 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 that codman hakim programmable valve with sg was implanted to an (b)(6)year old male patient via v-p shunt on (b)(6) 2021 with 80mmh2o.The pressure was changed to 60 after the operation and the patient had recovered.On (b)(6), the pressure was lowered to 30 because subcutaneous effusion had occurred.On (b)(6), shunt contrast was performed, and no clogging was noted.The patient returned to the hospital in may and a subcutaneous effusion under the dura mater was noted.Contrast was performed and the area after the valve was clogged.The valve was removed and replaced on (b)(6).No abnormality in cerebrospinal fluid was noted and a protein concentration of 140 was reported.The patient is in good condition.No further information was provided by hospital.

Manufacturer Narrative

The 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 30mmh2o.The valve was hydrated.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.The valve only leaked from the needle holes in the needle chamber.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.

Event Description

N/a.

• 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
• 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: 11967147
• MDR Text Key: 255165156
• Report Number: 3013886523-2021-00256
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823162
• Device Lot Number: 4175406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2019
• 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: 11 MO