MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE RIGHT ANGLE; CHPV

Model Number	823184
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
1 of 2 reports.Other mfg report number: 3013886523-2023-00072.A physician reported a hakim valve (id 823184) and a bactiseal catheter kit (id 823072) were implanted on (b)(6) 2022.A shunt blockage and malfunction occurred on february 07, 2023.The patient had interventricular hemorrhage on the fifth (5th) day after implantation.Due to blockage and malfunction the valve and the catheter were removed and replaced on (b)(6) 2023.
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.
Additional Manufacturer Narrative
The hakim valve (id 823184) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.However, a probable root cause for the reported complaint is biological debris and protein build up interfering with the valve.As no valve was returned for investigation this could not be confirmed.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: PROG VALVE RIGHT ANGLE
• Common Device Name: CHPV
• 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: 16478262
• Report Number: 3013886523-2023-00067
• Device Sequence Number: 3198639
• Product Code: JXG
• UDI-Device Identifier: 10381780519263
• UDI-Public: 10381780519263
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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 Model Number: 823184
• Device Catalogue Number: 823184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 04/18/2023
• 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: Male