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

Catalog Number	826653
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
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) 2024.The icp monitor was unable to detect the microsensor thirty hours after implantation.The microsensor was connected using another cable and icp monitor, but it still was not detected.The physician only used the microsensor for external ventricular drainage due to the issue and removed it on (b)(6) 2024.The sensor was not replaced.The patient did not experience any signs and symptoms and is in stable condition.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The microsensor (id 826653) was returned for evaluation.Device history record (dhr): review did not identify anomalies and/or deviations related to the reported issue.Failure analysis: internal wires broken inside drainage tube (x-ray).Proximal case glued to drainage tube.No testing possible.Root cause analysis: the device was evaluated and a broken internal wire and the proximal case glued to the drainage tube was identified.No testing was possible.A potential cause of the damage may be related to handling during preparation, insertion, and/or use.No manufacturing, workmanship, or material deficiency has been identified.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.Corrected field: d9.

• 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: 20040325
• Report Number: 3014334038-2024-00173
• Device Sequence Number: 15448049
• 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,Followup
• Report Date (Section B): 11/27/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 826653
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 10/17/2024; 11/27/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/07/2024; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• 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 CABLE (826636).; ICP MONITOR (826635).
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian