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

Model Number	82-6636
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional 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
• Common Device Name: 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
• Report Number: 3014334038-2023-00040
• Device Sequence Number: 5821885
• Product Code: GWM
• UDI-Device Identifier: 10886704042365
• UDI-Public: 10886704042365
• Combination Product (Y/N): N
• PMA/510(K) Number: K945585
• 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,Followup
• Report Date (Section B): 07/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 82-6636
• Device Catalogue Number: 826636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 07/12/2023
• Date Device Manufactured: 07/09/2014
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown