MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CHPV INLIN/SG INTEGRAL CON; CHPV WITH SG

Model Number	82-3842
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A physician reported a certas valve (unknown id) was implanted in a (b)(6) female via l-p shunt on (b)(6) 2019 with unknown setting.Due to shunt failure, a hakim v-p shunt (id 823842) was added on (b)(6) 2021.The v-p shunt pressure was reduced to 30 mmh2o and the patient was in the follow up.A year later, hydrocephalus was confirmed by ct and on (b)(6) 2022, the hakim valve (id 823842) was removed and replaced.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim valve was returned for evaluation.Device history record (dhr) - the valve, product code 82-3842 with lot 4335782, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; a needle hole in the needle chamber was noted.The position of the cam when valve was received was 30mmh2o.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: CHPV INLIN/SG INTEGRAL CON
• Common Device Name: 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: 13543403
• Report Number: 3013886523-2022-00055
• Device Sequence Number: 4299327
• Product Code: JXG
• UDI-Device Identifier: 10886704041856
• UDI-Public: (01)10886704041856(17)241231(10)4335782
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 82-3842
• Device Catalogue Number: 823842
• Device Lot Number: 4335782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown