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

Catalog Number	823045
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/22/2025
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 facility reported a hakim peritoneal catheter (id: 823045) was implanted via a lumboperitoneal (lp) shunt on an unknown date due to communicating hydrocephalus and secondary normal pressure hydrocephalus (snph).The catheter was used with a certas valve (id: 828804) and a silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).Shunt dysfunction was observed; therefore, the device was explanted on an unknown date.According to information provided, the details of the shunt dysfunction are unknown.It is unknown whether there is an identified issue with the peritoneal catheter.It is also unknown if the patient experienced any signs or symptoms due to the device issue.The current status of the patient is unknown.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim peritoneal catheter (id (b)(6)) was returned for evaluation.Failure analysis - the catheters were visually inspected; no defects noted.The catheters were irrigated, no occlusions noted.The catheters were leak tested; no leaks were noted.The complaint was unconfirmed.Root cause analysis - no root cause for the issue reported by the customer could be determined as no defects could be found with the catheter.A possible root cause for the issue reported by the customer, could be due to catheter susceptible to kinking which could lead to an 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: 21384768
• Report Number: 3013886523-2025-00037
• Device Sequence Number: 12854357
• 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): 04/30/2025

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?: 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): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 04/30/2025
• 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 (828804).; SILASCON LUMBAR CATHETER-KANEKA, (CODE: 702-JJ).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown