MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS RA SG UTZ BAC CATH ACC; BACTISEAL

Catalog Number	828827PL
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Confusion/ Disorientation (2553)
Date of Event	02/02/2026
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
This is 1 of 2 reports (same patient, different valves) linked to mfg report number: 3013886523-2026-00039.A facility reported a certas valve (id 828827pl) was implanted on (b)(6), 2026, programmed at 4.The patient had symptomatic relief post procedure.The patient went home well and on (b)(6) 2026, the patient was transferred to (b)(6) hospital.The patient had signs and symptoms of low-pressure hydrocephalus, swelling of his pseudomeningocele after it had been flat, confusion, and imbalance.Symptoms lasted for 3 days before arriving to the emergency room (er).The shunt was checked and was at setting 8, so they reprogrammed it to 4.The symptoms did not improve.X-ray the next day showed it back at 8.The physician commented that the nurse practitioner (np) may not have programmed it successfully, but maybe it changed back to an 8 again.On (b)(6) 2026, the patient was reprogrammed to a 4.Still, the patient¿s symptoms did not improve.Therefore, the valve was removed on (b)(6) 2026.Before the procedure, the physician used the manual programmer to set it at setting 4.The surgeon cut the distal catheter, and the valve did not have any cerebrospinal fluid (csf) flow.A new certas valve (id 828824pl) was implanted at setting 4 and had flow immediately.They checked the setting again after the valve passed off the field, and it was at 4.On (b)(6), the patient was doing great.On (b)(6) 2026, the new implanted valve was occluded and would not flush at all.The patient experienced low-pressure hydrocephalus symptoms.Therefore, the valve was removed and replaced.When the valve was removed, they tried flushing it on the back table, and it took extreme pressure for the fluid to make it through.The patient is doing well.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The certas valve (id 828827pl) was returned for evaluation: device history record (dhr) - the product code 82-8827pl with lot 7599256, conformed to the specifications when released to stock.Failure analysis - the position of the cam when the valve was received was at setting 4.The valve was visually inspected; the proximal connector is broken and unattached.The valve passed the test for programming.The occlusion, leak, reflux, siphon guard and pressure test could not be performed as the connector is broken.Root cause analysis - no root cause could be determined as the technician could not confirm any problem with the catheter and the valve at the time of investigation.The possible root cause for the reported issue could be due to biological debris, as per ifu: accumulation of biological matter within the valve can cause difficulties adjusting the valve setting with the tool kit and impair the anti-reflux function.Another potential root cause for the issue reported could be due to a kink of catheter.The possible root cause for the broken connector could be due to an excessive force applied on the device or a human misuse when remove the valve.
Event or Problem Description
N/a.

• Brand Name: CRTS RA SG UTZ BAC CATH ACC
• 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 ; 6099362319
• MDR Report Key: 24469560
• Report Number: 3013886523-2026-00032
• Device Sequence Number: 21243662
• Product Code: JXG
• UDI-Device Identifier: 10381780535867
• UDI-Public: (01)10381780535867(11)250924(17)260831(10)7599256
• Combination Product (Y/N): N
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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: 08/31/2026
• Device Catalogue Number: 828827PL
• Device Lot Number: 7599256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2025
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Race: White