MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD EDS DRAINAGE SYS NO V CATH; CSF DRAIN SYS/CRANIAL ACCESS

Catalog Number	821731C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Death
Event or Problem Description
A facility reported: "eds3 system was being used on a patient.Patient icp was also being monitored with a non-integra icp sensor/transducer and ge patient monitor." integra's account manager was contacted by the anaesthetic nurse on (b)(6) 2023 regarding the accuracy of eds3c when set up for icp monitoring.The account manager said they would speak with the professional education manager and get back to them.Then, in a second conversation, when relaying the product information back to the customer, the nurse confirmed there had been a patient death.The account manager said they need to report the information.The nurse responded with that it was very likely to be ¿human error and not related to eds3c¿.The account manager reiterated 3 times that they would like to report it but the nurse remained reluctant to give any further details.Additional information from sales representative.In another conversation of the integra's account manager with the neuro anum for theaters: "he said that the patient had not had an icp reading taken in recovery and was finally done on the ward when it was found to be high.He said it wasn¿t product related so wouldn¿t share any further information.I explained why the information was needed but was unable to get anything further.".
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
Eds drainage (id 821731c) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.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: EDS DRAINAGE SYS NO V CATH
• Common Device Name: CSF DRAIN SYS/CRANIAL ACCESS
• 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: 17968629
• Report Number: 3013886523-2023-00364
• Device Sequence Number: 6565426
• Product Code: JXG
• UDI-Device Identifier: 10886704079873
• UDI-Public: 10886704079873
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 821731C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 11/30/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown