MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR ICP EXPRESS CABLE; ICP EXPRESS - CABLES

Model Number 82-6636

Device Problem High Readings (2459)

Patient Problem Insufficient Information (4580)

Event Date 03/07/2023

Event Type  malfunction  

Event Description

This is 2 of 4 reports linked to mfg report numbers: 3013886523-2023-00090, 3014334038-2023-00041, 3013886523-2023-00091.A facility reported a cerelink sensor (id (b)(4)) was implanted in operative room for monitoring intracranial pressure (icp) of an acute subarachnoid hemorrhage, but once the dressing was placed, the reading became abnormally high.A new cerelink sensor was inserted and the readings were stable.Patient was transferred to icu but overnight, the readings became abnormally high and erratic.Medication was given to bring icp down, however the patient did not respond, although did not appear to be symptomatic either.The sensor was removed at bedside on (b)(6) 2023 and an evd was inserted which gave a normal icp reading.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The icp express cable (id 826636) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Serial 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 used in this investigation is: monitor calibration service not done.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: ICP EXPRESS CABLE
• Type of Device: ICP EXPRESS - CABLES
• 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: 16655821
• MDR Text Key: 313308309
• Report Number: 3014334038-2023-00040
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 10886704042365
• UDI-Public: 10886704042365
• Combination Product (y/n): N
• PMA/PMN Number: K945585
• 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,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 82-6636
• Device Catalogue Number: 826636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2023
• Date Device Manufactured: 07/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1