MAUDE Adverse Event Report: GALT MEDICAL CORP GALT FLUENT MICRO-INTRODUCER; PERCUTANEOUS SHEATH INTRODUCER KIT

Lot Number	G23041302
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During an attempt to place a midline catheter, the guidewire became stuck in the patient's arm (noted to be located in subcutaneous tissue).There was difficulty in backing the wire out, therefore, vascular surgery was consulted.As attempts were being made at wire removal by vascular surgery, the wire broke.A medical decision was made to leave the broken piece of the wire inside the patient.This was reported as the 3rd time in which this proceduralist has seen the wire tip encircle itself into forming a small knot.In the previous 2 cases, the wire was simply removed.In this case, the wire became stuck and required consultation by vascular surgery and a trip to the operating room for attempted removal of the wire.Note: this guidewire was used while attempting to place a bard powermidline catheter.

• Brand Name: GALT FLUENT MICRO-INTRODUCER
• Common Device Name: PERCUTANEOUS SHEATH INTRODUCER KIT
• Manufacturer (Section D): GALT MEDICAL CORP
• MDR Report Key: 18122243
• Report Number: MW5148047
• Device Sequence Number: 6449145
• Product Code: OFL
• UDI-Device Identifier: 00841268104549
• UDI-Public: (01)00841268104549
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/08/2023

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?: Yes
• Operator of Device: Health Professional
• Device Lot Number: G23041302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White