MAUDE Adverse Event Report: Integra LifeSciences Switzerland SAR CERTAS PLUS INLINE WITH SIPHON 828807PL; Bactiseal

Catalog Number	828807PL
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Headache (1880)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A sales representative stated: "patient is a 68-year-old man with normal pressure hydrocephalus.He was shunted in december 2025 and has been having unpredictable responses to valve changes ever since.Patient had subdurals that had to be managed, but not surgically.Recently, his ventricles had collapsed down with small extra axial collections.The physician turned the valve off to 8 and his ventricles remained collapsed with small extra axial collections.He was neurologically doing very well but was having low pressure headaches." "the physician assumed that the valve was defective now that it was set at 8 and the ventricles were not filling up.He felt the valve was probably just staying open and continued to drain.Ultimately, with the postural headaches continuing, the physician really didn't like looking at slit ventricles and small axials so with the hypothesis of the defective valve, the valve being stuck open, despite being set at 8, the physician put him on the schedule to replace what he thought was a defective valve.That was scheduled for next week, but yesterday on (b)(6), he came in with asymptomatic hydro.Images were close to his pre-op scan.The physician reprogrammed the valve to 7 and today, on (b)(6), his ventricles are normal." "the physician still explanted the valve with the hypothesis that it was intermittently working.He believed it started working by itself.He thinks it has been stuck in the open position since january, so he took it out.After removing it, he benches tested it with a manometer, went at a setting of 7 manometers slowly dropped to between 15 and 16 centimeters of water.The physician thinks the valve is working now." "ultimately he thinks that it has not been working for several months.His hypothesis is that it has been stuck open, despite being set at 8 for months.Then, for reasons that he is ¿equally befuddled about, it shut down and started working again.¿ the rest of his shunt is working (distal and ventricular catheters).".
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.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON 828807PL
• Common Device Name: Bactiseal
• 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 08540 ; +1(609)936-2319
• MDR Report Key: 50175253
• Report Number: 3013886523-2026-00198
• Device Sequence Number: 15521410
• Product Code: JXG
• UDI-Device Identifier: 10381780535430
• UDI-Public: (01)10381780535430(11)251114(17)261031(10)7624127
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 828807PL
• Device Lot Number: 7624127
• Date Returned to Manufacturer: 08/21/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male