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

Catalog Number 826638

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported the icp sensor was not placed firmly even though the skull bolt was tightened.Therefore, it was changed to another one and procedure was completed with no surgical delay, no adverse consequences to the patient.

Manufacturer Narrative

Unique device identifier (udi)- (b)(4).Device history record (dhr)- all process steps were followed and completed with no non-conformances.There is no indication that the production process may have contributed to this complaint.Released to stock on 20th march 2019.Failure analysis- there was no visible damage to the millar sensor or connector.Catheter material pinched/crimped 26cm from tip.The device passed electronic, noise, linearity/hysteresis, and signal drift tests the 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 the incompatibility with perforator.

• Brand Name: MICROSENSOR KIT W/ SKULL BOLT
• Type of Device: ICP MICROSENSORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10280869
• MDR Text Key: 202941402
• Report Number: 1226348-2020-00289
• 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
• Type of Report: Initial,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 826638
• Device Lot Number: 3500995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1