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

Model Number	82-3842
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
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 hakim valve (id 823842) was implanted via unknown-shunt on unknown date with unknown setting.Due to underdrainage 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 underdrainage.
Additional Manufacturer Narrative
The hakim valve was returned for evaluation.Failure analysis - the valve was visually inspected; needle holes in the needle chamber were noted, and some biological debris floating in the needle chamber.The position of the cam when valve was received was 50mmh2o.The valve was hydrated.The catheter was irrigated, no occlusions noted.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 under drainage 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 under drainage 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: 14633122
• Report Number: 3013886523-2022-00256
• Device Sequence Number: 6126199
• Product Code: JXG
• UDI-Device Identifier: 10886704041856
• UDI-Public: (01)10886704041856(17)210430(10)CVFCVL
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 82-3842
• Device Catalogue Number: 823842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2016
• 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