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

Model Number	826845
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
This is 3 of 3 reports linked to mfg report number: 3013886523-2022-00134, 3014334038-2022-00068.A facility reported a cerelink microsensor was placed in the left side of the brain in a (b)(6)-month-old patient with traumatic brain injury.The reading went to -10, then the cerelink monitor alarmed "sensor failure", then went to "sensor /cable failure".The cables and monitor were replaced; however, it was still reading a negative icp.Then the sensor was replaced and placed in the right side of the brain with a new cerelink monitor and the sensor was working as intended.
Additional Manufacturer Narrative
Additional information received indicates the following: implant location: parenchymal.Did the failure occur during patient movement? (i.E.Reposition, transport, out of bed for bathroom, ambulate, chair, etc.): after a.Was a movement assistance device used? if yes, please specify.: unknown.B.Amount of time between patient movement and failure event.: was working in or, but read negative and had error message in icu.C.Was the microsensor disconnected from the cerelink monitor during each phase of transport? : unknown.D.Did the patient receive an mri or ct scan before the failure occurred? : no.What was the mean icp before the ¿event¿? icp value: unknown.What was the icp waveform quality before the ¿event¿? unknown.What is the current mean icp?: n/a ¿ placed second sensor opposite side of brain and stopped monitoring sensor in question.What is the icp waveform quality after the ¿event¿?: unknown.When the failure occurred, was the cerelink monitor plugged into the wall? unknown.When the failure occurred, was the cerelink monitor connected to a patient monitor? unknown.A.Does the icp value on cerelink match the icp value on the patient monitor? unknown.When the failure occurred, where was the cerelink monitor positioned? unknown.List all devices being used close to the cerelink monitor: unknown.Other devices implanted in the head? (shunt, evd, subdural drain).If yes, specify unknown.Were bipolar or monopolar forceps used while the sensor was plugged in? unknown.Provide a description of any unusual events or issues that occurred during the implantation or during the patient care unknown.Describe the quality of the insertion: unknown.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The cerelink cable was returned for evaluation.Device history record (dhr) - lot 4817361, conformed to the specifications when released to stock.Failure analysis - the cable was cleaned with isopropyl alcohol 70% and visually inspected: no defect was noted.The cable was inspected for connector alignment and no defect was noted.The cable was electrically tested and no abnormal discontinuity and no abnormal short circuit was measured.The cable meets the specifications.No root cause could be determined as the technician could not confirm any problem with the cable at the time of investigation.The possible root cause for the problem reported by the customer could be due to an inappropriate technique for assembly and use of the device.
Event or Problem Description
N/a.

• Brand Name: CERELINK ICP EXT CABLE
• Common Device Name: CERELINK - 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: 14084003
• Report Number: 3013886523-2022-00146
• Device Sequence Number: 5317756
• Product Code: GWM
• UDI-Device Identifier: 10381780520665
• UDI-Public: (01)10381780520665(10)4817361
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2022

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: 826845
• Device Catalogue Number: 826845
• Device Lot Number: 4817361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 04/19/2022; 06/01/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 04/29/2022; 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2020
• 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
• Patient Age: 18 MO
• Patient Sex: Unknown