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

Catalog Number	823045
Medical Device Problem Codes	Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a hakim peritoneal catheter (id 823045) and a connector (id 823053) were implanted in a 42 year-old male patient via ventriculoperitoneal shunt on (b)(6) 2023.The catheter was connected to a competitor¿s valve which was already implanted.On (b)(6), 2023, overdrainage was observed.A shunt contrast was performed and cerebrospinal fluid (csf) leakage from the catheter was found.On (b)(6) 2023, the catheter was explanted and replaced, connector remained implanted.According to information provided, it is unknown if the patient experienced any signs and symptoms due to overdrainage and csf leakage.
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
N/a.
Additional Manufacturer Narrative
The hakim valve (id 823045) was returned for evaluation.Failure analysis - the catheter was visually inspected; no defects were noted.The catheter was irrigated, no occlusions were noted.The valve was leak tested; leaks were noted.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 issue reported by the customer could be due to biological debris and protein build up interfering with the catheter.At the time of investigation, no function issues were noted.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18192182
• Report Number: 3013886523-2023-00392
• Device Sequence Number: 7275419
• 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
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 01/19/2024

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 Catalogue Number: 823045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 01/19/2024
• 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: SHUNT CONNECTOR (ID 823053)
• Patient Age: 42 YR
• Patient Sex: Male