MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD HAKIM PERITON CATH,120CM; STANDARD CATHETERS

Catalog Number	823045
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); Cerebral Ventriculomegaly (2133)
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 physician reported a peritoneal catheter (b)(6) was implanted via lumboperitoneal (l-p) shunt due to ventricular dilatation 6 months ago.On an unknown date, a leak and infection were noted.The cause of infection was due to a leakage from the part where a lumbar puncture was performed.The catheter was used along with the certas valve (b)(6) products were removed and replaced by an external ventricular drainage system.Based on information provided, it is unknown which device was removed, it is also unknown the type of infection/organism and the tests used to confirm it.The treatment or medication used to treat the infection is unknown.Primary disease: secondary normal pressure hydrocephalus (snph).
Additional Manufacturer Narrative
A peritoneal catheter (id 823045) was returned for evaluation.Failure analysis - the 485mm of catheter was visually inspected no kinks were noted, the ends of the catheter were clean cut.The catheter was irrigated, no occlusion was noted.The catheter was leak tested and no leaks were noted.All finished goods test results, including endotoxin satisfactorily met the requirements.Root cause analysis - no root cause could be determined as the technician could not confirm any problem with the catheter at the time of investigation.A possible root cause for the ¿after surgery, there was a leakage¿ issue reported by the customer could not be determined as the technician could not confirm any leaks with the catheter at the time of investigation.A possible root cause for the ¿the kink in the lumbar catheter was suspected¿ issue reported by the customer could be due to the length of the catheter being too long or an issue when implanting the catheter as catheter more susceptible to kinking which leads to occlusion.

• Brand Name: HAKIM PERITON CATH,120CM
• Common Device Name: STANDARD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19466934
• Report Number: 3013886523-2024-00159
• Device Sequence Number: 12625601
• Product Code: JXG
• UDI-Device Identifier: 10381780518839
• UDI-Public: 10381780518839
• Combination Product (Y/N): N
• PMA/510(K) Number: K944222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 823045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CERTAS VALVE (ID 828804); LUMBAR CATHETER (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female