MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MICROSENSOR KIT W/ SKULL BOLT; ICP MICROSENSORS

Catalog Number 826638

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/10/2023

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 physician reported a microsensor (id 826638) was implanted in a female patient on an unknown date.When placing, the cap part of skull bolt came off so spongel was used to secure the sensor.The pressure increased to 36mmhg and no acute findings in computed tomography (ct) scan as well as no signs of neurological symptoms were noted.Ct scan showed that the tip of sensor was placed in between the inside and in the skull.The product was explanted on unknown date since it could not measure the precise pressure and there were no signs of bleeding.

Manufacturer Narrative

Microsensor (id 826638) was not returned for evaluation as the product is not available for return as per customer; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.However, a probable root cause for the reported complaint could be due to probe connector housing that is impacted by external force.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

The microsensor (id 826638) was returned for evaluation.Device history record (dhr) - the product 826638 for lot 6860132 (sn (b)(6)), and the lot met specifications when released.Failure analysis - no visible damage to the millar sensor, catheter or connector.Icp express read 501.The device passed electronic, noise, linearity/hysteresis and signal drift tests.Root cause analysis - the exact root cause of the issue reported by customer could not be determined as the device worked correctly.However, the possible root cause of the defect reported by the customer could be due to probe connector housing that is impacted by external force.

Event Description

N/a.

• Brand Name: MICROSENSOR KIT W/ SKULL BOLT
• Type of Device: ICP MICROSENSORS
• 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: 18247562
• MDR Text Key: 329495741
• Report Number: 3013886523-2023-00403
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K914479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 826638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2022
• 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
• Patient Sex: Female