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

Catalog Number 826653

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2024

Event Type  Injury  

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 Description

A facility reported a microsensor (b)(6) was implanted on (b)(6) 2024 at 6:00pm, and around 10:30 pm, the microsensor was found leaking a moderate amount of cerebrospinal fluid (csf), the surgical dressing was wet.On january 10, 2024, the physician found that there was no more cerebrospinal fluid (csf) leaking, and retrieved the microsensor.The sensor was not replaced and the patient did not experience any signs and symptoms due to csf leaking.The patient is in good condition.The monitor used was icp express monitor (b)(6), cable used was icp express cable (b)(6).

• Brand Name: MICROSENSOR VENTRICULAR CATHETER KIT
• Type of Device: 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 ; 6099362319
• MDR Report Key: 18838848
• MDR Text Key: 336916197
• Report Number: 3014334038-2024-00047
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K991222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 826653
• Device Lot Number: 6647443
• Initial Date Manufacturer Received: 02/18/2024
• Initial Date FDA Received: 03/05/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ICP CABLE (B)(6).; ICP MONITOR (B)(6).
• Patient Age: 47 YR
• Patient Sex: Male