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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Type of Reportable Event	Serious Injury
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
A facility reported a eds drainage catherer (id 821731c) was placed on (b)(6) 2023 for the treatment of hydrocephalus following subarachnoid hemorrhage due to ruptured cerebral aneurysm.13 days later there was a csf leak through the eds drainage catheter.The drainage system (821731c) was replaced, and the catheter for the external ventricular drainage (ins-8420) stayed implanted.
Additional Manufacturer Narrative
The eds drainage system was returned for evaluation: failure analysis - the eds was visually inspected: cracks and stress marks were noted in the patient line connector.The eds was set up per ifu.The eds was flushed leaked from the connector.The current quality inspection for these assemblies is established to 100% test for leaks and blockage.Complaint confirmed.Root cause - the root cause for the for the cracks and stress marks found in the connector are due to over tightening when connecting devices, as noted in the ifu finger tighten only.The root cause for the leakage reported by the customer is due to the cracked connector.
Event or Problem Description
N/a.

• 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: 16854484
• Report Number: 3013886523-2023-00128
• Device Sequence Number: 6526508
• Product Code: JXG
• UDI-Device Identifier: 10886704079873
• UDI-Public: 10886704079873
• Combination Product (Y/N): N
• PMA/510(K) Number: K061568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/27/2023

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 Catalogue Number: 821731C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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