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

Catalog Number	826638
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that after doing step by step the calibration of the microsensor with the directlink, it was not possible to achieve a curve and number in the bedside monitor, only a question mark appears.They recalibrate the microsensor following the instructions without obtaining results, therefore, the sensor was explanted.The event led to 4 hours delay in the procedure, however, no anesthesia was involved as the patient was already sedated and intubated in the icu.
Additional Manufacturer Narrative
Microsensor (id 826638) was not returned for evaluation due to biological contamination; 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, the possible root cause for this issue reported by the customer could be due to a user error.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.

• Brand Name: MICROSENSOR KIT W/ SKULL BOLT
• Common Device Name: 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: 18192903
• Report Number: 3013886523-2023-00400
• Device Sequence Number: 7321584
• Product Code: GWM
• UDI-Device Identifier: 10381780520504
• UDI-Public: (01)10381780520504(17)270831(10)6694033
• Combination Product (Y/N): N
• PMA/510(K) Number: K914479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2023

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 Catalogue Number: 826638
• Device Lot Number: 6694033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 11/22/2023
• Date Device Manufactured: 09/15/2022
• 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: DIRECT LINK (ID 826828); PHILLIPS MONITOR INTERFACE CABLE (ID 826881)
• Patient Sex: Male
• Patient Race: White