MAUDE Adverse Event Report: ABBOTT MEDICAL EPIDURAL NEEDLE, 14 GAUGE, 6" (15CM)

Model Number	1116
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A cerebrospinal fluid leak (csf) during implantation was reported to abbott.Patient had high impedances on contacts 9-16 which prevented them from getting a needed mri.The doctor planned on revising the system but decided to explant the system.After explanting all components, the doctor attempted to access the epidural space and punctured the dura.The case was aborted and incisions were closed.No further intervention planned.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported a cerebrospinal fluid leak (csf) occurred while the physician was attempting to access the epidural space.The procedure was then aborted and all incisions were closed.No further intervention is pending.

• Brand Name: EPIDURAL NEEDLE, 14 GAUGE, 6" (15CM)
• Common Device Name: EPIDURAL NEEDLE
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15203797
• Report Number: 1627487-2022-04355
• Device Sequence Number: 2109356
• Product Code: LGW
• UDI-Device Identifier: 05414734400145
• UDI-Public: 05414734400145
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2022

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 Model Number: 1116
• Device Catalogue Number: 1116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 113 KG