MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP VENTRICULAR CATH; IPC - CATH - CERELINK

Model Number	826854
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a cerelink monitor gave error that sensor or patient cable is faulty.Troubleshooting was done as per ifu.Different monitor was connected to probe and same error persisted.When surgeon removed the probe in operative room it became apparent that the ventricular drain was occluded.A new sensor was inserted.
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
Complaint sample was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - product was returned and the following was concluded: 1- catheter was evaluated at drainage tube and inside drainage tube.2- internal wires broken, cerelink monitor reading was unacceptable: icp express read "no transducer detected." 3- no testing possible.Based on the evaluation we were able to confirm the complaint and determine the cause of the problem stated to be mishandling of the catheter.Therefor the complaint condition could be confirmed.

• Brand Name: CERELINK ICP VENTRICULAR CATH
• Common Device Name: IPC - CATH - CERELINK
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15406885
• Report Number: 3014334038-2022-00203
• Device Sequence Number: 6840005
• Product Code: GWM
• UDI-Device Identifier: 10381780520702
• UDI-Public: 10381780520702
• Combination Product (Y/N): N
• PMA/510(K) Number: K173192
• 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): 12/01/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 826854
• Device Catalogue Number: 826854
• Device Lot Number: 1723053110JH57660911320
• 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: 08/25/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2021
• 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 Sex: Unknown