MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV ONLY W/SPHNGD; CERTAS PLUS W/ SG

Catalog Number 828804

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 02/20/2024

Event Type  Injury  

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 Description

This is 1 of 2 reports linked to mfg report number 3013886523-2024-00062.A physician reported a certas valve (id 828804) and a bactiseal peritoneal catheter (id 823074) were implanted due to secondary normal pressure hydrocephalus (snph) via lumbar peritoneal (lp) shunt on january 30, 2024 with unknown setting.The valve was used with the silascon® lumbar catheter (manufactured by kaneka, product code: 702-jj).After the implantation, cerebrospinal fluid (csf) was accumulated around the valve; therefore, the setting was set lower.Despite treatment was performed due to suspected cerebrospinal fluid leakage (csf), the situation did not improve.A revision surgery was performed, and the certas valve (id 828804) was explanted on (b)(6), 2024.A lumbar peritoneal (lp) shunt was removed and replaced with a ventriculoperitoneal (vp) shunt.Upon explanting, it was confirmed that the proximal catheter was detached from the valve.In addition, lumbar catheter was partially ruptured.The primary condition of the patient is intracerebral hemorrhage.According to information provided, it is unknown if the patient experienced any signs and symptoms due to suspected cerebrospinal fluid (csf) leakage.The treatment performed is also unknown.

• Brand Name: CERTAS INLIN VLV ONLY W/SPHNGD
• Type of Device: CERTAS PLUS W/ 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: 18840922
• MDR Text Key: 336959436
• Report Number: 3013886523-2024-00061
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828804
• Device Lot Number: 7303019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BACTISEAL PERITONEAL CATHETER (ID 823074); SILASCON® LUMBAR CATHETER (702-JJ)
• Patient Sex: Female