MAUDE Adverse Event Report: GALT MEDICAL CORPORATION FLUENT TRANSITIONLESS STIFFEN MICRO-INTRODUCER KIT; FLUENT STIFFEN MICRO-INTRODUCER KIT

Model Number	KIT-039-03
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history records have been reviewed for main product and subcomponents and there were no incidents or abnormality indicated.All parts have been manufactured according to galt internal drawing specifications.One sample was returned and the complaint was confirmed.Galt took some photos for returned sample, images shows no damage occurrence to the distal tip after retrieved from patient; ball weld finishing was properly done.Additional images show loosens exactly after the distal tip portion, various angles of mandrel portion towards proximal was cut off and mandrel has been twisted due to over torque and using wrong angle during insertion or retrieving the wire from patient that means unit was submitted to excessive force.Other images show the remainder of mandrel cutting portion towards distal coiled and discoloration occurrence to the mandrel due to using torque force.According to end user report "the wire was placed and the catheter was advanced over the wire, the catheter was then removed and a peel away sheath placed during a repeat access it was noted the floppy end of the wire had been fractured.Using ultrasound and a gooseneck snare device, the floppy end of the wire was removed in its entirety".Based on investigation and evaluations this was determined to be end user error (end user didn't follow ifu).Recommendations were made to end user to adhere to instruction for use that shipped along with each single kit under (lab-021-00k).
Event or Problem Description
As received from end user to manufacturer: the patient required a chest port for chemotherapy.When placing port under fluoroscopy, the right internal jugular was identified.The wire was placed and the catheter was advanced over the wire, the catheter was then removed and a peel away sheath placed during a repeat access it was noted the floppy end of the wire had been fractured.Using ultrasound and a gooseneck snare device, the floppy end of the wire was removed in its entirety.

• Brand Name: FLUENT TRANSITIONLESS STIFFEN MICRO-INTRODUCER KIT
• Common Device Name: FLUENT STIFFEN MICRO-INTRODUCER KIT
• Manufacturer (Section D): GALT MEDICAL CORPORATION; 2220, 6137, merritt dr; garland TX 75041
• MDR Report Key: 8575389
• Report Number: 1649395-2019-00004
• Device Sequence Number: 10858017
• Product Code: DQX
• UDI-Device Identifier: 10841268104584
• UDI-Public: 10841268104584
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K021990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/19/2019
• Report Date (Section F): 05/02/2019

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: No Information
• Device Expiration Date: 11/28/2022
• Device Model Number: KIT-039-03
• Device Lot Number: G18278173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 05/02/2019