MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MICROSENSOR VENTRICULAR CATHETER KIT; ICP MICROSENSORS (ROHS)

Catalog Number	826653
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	09/26/2023
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 microsensor (id 826653) was implanted on (b)(6) 2023 and 3 days after the procedure, the microsensor was leaking cerebrospinal fluid (csf).Then the physician retrieved the product and stop monitoring.It was explanted on (b)(6) 2023.The monitor used was icp express, 220 volt (id 826635) and the cable used was icp express cable (id 826636).
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The microsensor (id 826653) was returned for evaluation.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - upon receipt, the complaint unit is initially assessed to be in good condition.Minor signs of use are apparent throughout the catheter.A slit opening is identified on the catheter against the white barium lumen close to the tip.The icp transducer seems to be in good condition with no signs of any damage that could potentially affect its functionality.Utilizing a known good external drainage collection bag, a leak test was performed with the complaint unit and passed.Showing no signs of leakage throughout the catheter including the slit identified.Root cause analysis - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.Per the failure evaluation results, the likely root cause is mishandling/misuse.

• Brand Name: MICROSENSOR VENTRICULAR CATHETER KIT
• Common Device Name: ICP MICROSENSORS (ROHS)
• 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 08540 ; 6099362319
• MDR Report Key: 17926400
• Report Number: 3014334038-2023-00170
• Device Sequence Number: 16883258
• Product Code: GWM
• UDI-Device Identifier: 10381780520566
• UDI-Public: 10381780520566
• Combination Product (Y/N): N
• PMA/510(K) Number: K991222
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2024

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 Expiration Date: 07/31/2024
• Device Catalogue Number: 826653
• Device Lot Number: 6568698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 06/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• 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: ICP EXPRESS CABLE ID 826636; ICP EXPRESS MONITOR ID 826635
• Patient Sex: Unknown