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

Model Number	826854
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a cerelink ventricular catheter showed a kink therefore, no measurements were possible.The catheter was explanted and replaced on (b)(6) 2022 two to three days after implantation.No patient symptoms due to malfunction reported.
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
N/a.
Additional Manufacturer Narrative
The catheter was returned for evaluation: dhr - serial number (b)(6) was found to meet all criteria for release and was approved for use.Failure analysis - catheter received with drainage tube and material stretched at 2.8cm and 10cm from connector.Multiple kinks in catheter.Internal wires broken.Cerelink monitor reading was unacceptable; icp express read "no transducer detected.No testing possible.Therefore, the complaint condition could be confirmed.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.A device history record (dhr) review and trending were performed as part of the evaluation.Proper finished goods testing was performed prior to release as indicated in the dhr.Product was received for analysis and the investigation could confirm the complaint.

• 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: 15243365
• Report Number: 3014334038-2022-00180
• Device Sequence Number: 17316834
• 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
• Device Explanted Year: 2022
• 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): 01/13/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 826854
• Device Catalogue Number: 826854
• 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: 08/02/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2020
• 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 Sex: Unknown