MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MICROSENSOR BASIC KIT R; ICP MICROSENSORS (ROHS)

Catalog Number 626631

Device Problem High Readings (2459)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2022

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

3 of 3 reports.Other mfg report numbers: 3014334038-2022-00293, 3013886523-2022-00593.A facility reported a microsensor was implanted on (b)(6) 2022 in a male patient of approximate 8 years-old.A few minutes after implantation the icp readings jumped from clinical to 40.Due to the issue the microsensor was replaced.The patient went to picu (pediatric intensive care unit) with normal icp reading, however, approximately 1 hour later the sensor jumped to 40; then the second microsensor was explanted.It was also found that icp express cable was faulty (id: (b)(4) but not the monitor.

Event Description

N/a.

Manufacturer Narrative

The microsensor was returned for evaluation has been returned for evaluation.Device history record (dhr)- the product 626631 for lot 5958236 (sn (b)(6)), and the lot met specifications when released.Failure analysis- the issue of the complaint has been confirmed.No visible damage to the millar sensor or connector.Icp express = no transducer detected.Internal wires broken.Catheter stretched 3cm and 12.5cm from sensor.No testing was possible.The root cause of the issue reported could be determined as a mishandling of the catheter.

• Brand Name: MICROSENSOR BASIC KIT R
• Type of Device: ICP MICROSENSORS (ROHS)
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16106994
• MDR Text Key: 306747300
• Report Number: 3013886523-2023-00001
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K153347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 626631
• Device Lot Number: 5958236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2021
• 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: Male