MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD HAKIM VENTRICULAR CATH; STANDARD CATHETERS

Catalog Number	823041
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/19/2024
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 linked to mfg report number: 3013886523-2024-00267 a physician reported a ventricular catheter (id 823041) and a peritoneal catheter (id 823045) were implanted via ventriculoperitoneal (vp) shunt on unknown date with unknown setting.The catheters were used together with a certas plus valve (id 828804).All three devices were removed on an unknown date due to the valve not functioning properly after implantation.Based on information provided, it is unknown if there was an issue with the catheters, however, they were explanted.It is also unknown if the patient experienced any signs or symptoms due to valve failure.The patient's condition is unknown.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim ventricular catheter (b)(6) was returned for evaluation.Device history record (dhr) - the product code 82-3041 with lot 7121717, conformed to the specifications when released to stock.Failure analysis - the catheter was visually inspected; no defects noted.The catheter was irrigated, no occlusions noted.The catheter was leak tested, no leaks were noted.The complaint was unconfirmed.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.The 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 VENTRICULAR CATH
• 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: 20150751
• Report Number: 3013886523-2024-00266
• Device Sequence Number: 8301989
• Product Code: JXG
• UDI-Device Identifier: 10381780518815
• UDI-Public: (01)10381780518815(17)280229(10)7121717
• 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): 01/02/2025

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: 823041
• Device Lot Number: 7121717
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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 PLUS W/ SG (B)(6); PERITONEAL CATHETER (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown