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

Catalog Number	826653
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a microsensor (id 826653) was implanted on (b)(6) 2024.After the patient was sent back to the ward, the microsensor could not show intracranial pressure (icp) readings when it was reconnected to the icp monitor.The reported microsensor was removed and stopped the monitoring on (b)(6) 2024.The patient is stable.The icp monitor used with the sensor was the icp express, 220 volt (id 826635) and the cable was the icp express cable (id 826636).
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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.Device history record (dhr) - the batch record was reviewed for any anomalies or report related to the finished device, and none were identified.Failure analysis - internal wires broken/damaged inside drain tube (x-ray).Icp express read "no transducer detected".No testing possible.Complaint confirmed.Root cause analysis - the returned device presents with the internal wires broken inside a drain tube.Functional testing could not be performed due to the damage.A potential contributor to the reported failure may be related to handling of the device.
Event or Problem Description
N/a.

• 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 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: 19282323
• Report Number: 3014334038-2024-00096
• Device Sequence Number: 12656836
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• 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: 826653
• Device Lot Number: 7058662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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: ICP EXPRESS CABLE ID 826636.; ICP EXPRESS MONITOR ID 826635.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown