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

Model Number 82-3162

Device Problem Pressure Problem (3012)

Patient Problem Failure of Implant (1924)

Event Date 05/06/2022

Event Type  Injury  

Event Description

A physician reported a prog valve inline w sg (id 823162) was implanted via v-p shunt over 10 years ago with 110 mmh2o.The set pressure was not changed, therefore an attempt was made to change the set pressure from 110mm h2o to 90 mm h2o, however, it could not be changed.The valve was removed and replaced on (b)(6) 2022.Based on information provided, it is unknown if the patient experienced any signs and symptoms due to the issue.

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

N/a.

Manufacturer Narrative

The hakim valve (id 823162) was returned for evaluation.Device history record (dhr) - the product code 82-3162 with lot cmhcz6, 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 120mmh2o.The valve was hydrated.The valve was tested for programming; the valve failed, the cam mechanism wriggled.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve was retested for programming and passed the test.The valve passed the test for occlusion, reflux, siphon guard and pressure.The valve was visually inspected under microscope at appropriate magnification: biological debris was found on the cam mechanism.The root cause for the issue reported by the customer, was due to biological debris and protein build up interfering with the valve mechanism.

• 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: 14497755
• MDR Text Key: 292734938
• Report Number: 3013886523-2022-00219
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10886704041559
• UDI-Public: (01)10886704041559(17)160630(10)CMHCZ6
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: 82-3162
• Device Catalogue Number: 823162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 06/24/2022
• Supplement Dates FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2011
• 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