MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PV INLIN UNIT INTEGRAL CON L; PRECISION

Model Number	82-3807
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/01/2022
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 facility reported a hakim valve (id 823807) was implanted on (b)(6) 2022.The unitized shunt is broken at the point where distal catheter is connected to the valve.It was clearly seen on the x-ray that the distal catheter was no longer connected to the valve.The patient began to exhibit clinical signs of hydrocephalus on (b)(6) 2022 and a radiograph was performed which showed the shunt defect.Information received on (b)(6) 2022 indicates the care plan is to see if the patient can be medically managed before deciding to do another surgery and replace the valve.In regards the clinical signs, medical staff is still waiting to see if medical management is sufficient.
Additional Manufacturer Narrative
The hakim valve (id 823807)  was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.However, a probable root cause for the reported complaint is could be due to the valve receiving a hard knock or the silicone being cut/torn when implanted, as the device was not returned this could not be determined.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.
Event or Problem Description
N/a.

• Brand Name: PV INLIN UNIT INTEGRAL CON L
• Common Device Name: PRECISION
• 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: 15337402
• Report Number: 3013886523-2022-00395
• Device Sequence Number: 12485186
• Product Code: JXG
• UDI-Device Identifier: 10886704041733
• UDI-Public: 10886704041733
• Combination Product (Y/N): N
• PMA/510(K) Number: K944222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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 Model Number: 82-3807
• Device Catalogue Number: 823807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 09/15/2022
• 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