MAUDE Adverse Event Report: GALT MEDICAL CORP 5F FLUENTTM TRANSITIONLESS MICRO-INTRODUCER, 10CMX018" X 40CM NITI/GOLD GWA ECO; KIT-038-04

Model Number	KIT-038-04
Health Effect - Clinical Codes	Occlusion (1984); Foreign Body In Patient (2687)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint sample, guidewire returned.As part of investigation the dhrs has been reviewed and there is no abnormality recorded during manufacturing process.Evaluation on returned sample indicates that end user may remove the guidewire over the needle while the needle was still in place.Pictures for returned sample show the tip of guidewire broke off and coiled portion has been separated from the tip.The tip was also sheared off and unraveled due to multiple insertion attempts of guidewires over the needle.Ifu stating; do not withdraw the guidewire through metal needles as guidewire may shear or unravel.At no time should guidewire be advanced or withdrawn when resistance is met.Determine cause of resistance before proceeding.If the guidewire must be withdrawn while needle is inserted, remove both the needle and the wire as a unit to prevent the needle from damaging or shearing of the guidewire.Cannula must be removed first.Possible root cause for this occurrence determined to be end user did not follow ifu.
Event or Problem Description
As received from sales rep.(micro puncture broke off in a patient.Come to find out the wire sheared off, and a piece of the wire got stuck in the patient).The patient is okay.The piece of wire that sheared off did occlude the circumflex artery.Doctor (b)(6) said the patient should be fine.

• Brand Name: 5F FLUENTTM TRANSITIONLESS MICRO-INTRODUCER, 10CMX018" X 40CM NITI/GOLD GWA ECO
• Common Device Name: KIT-038-04
• Manufacturer (Section D): GALT MEDICAL CORP; 2220 merritt dr #100; garland TX 75041
• MDR Report Key: 11380634
• Report Number: 1649395-2021-00002
• Device Sequence Number: 14419308
• Product Code: OFL
• UDI-Device Identifier: 10841268104553
• UDI-Public: 10841268104553
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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 Expiration Date: 09/07/2024
• Device Model Number: KIT-038-04
• Device Lot Number: G20206676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 02/25/2021
• 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