MAUDE Adverse Event Report: GALT MEDICAL CORP. MICRO-INTRODUCER KIT

Model Number	KIT-002-27
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One sample was returned and the complaint was confirmed.Manufacturer took some pictures for subcomponent gwa-055-41 (guidewire 0.018 inches x 40 cm ss mandrel galt gold coil).Pictures shows that the core wire has been broken from distal tip and coiled part unraveled/sheared off from distal tip as well.The core wire was broken about 3 cm from distal tip and evaluation from pictures in failure investigation report shows the wire was cut due to cutting edges of 21 ga x 2.75 inch needle.Evidence from customer initial report stated that the wire withdrew over the needle while the needle was still in place.Customer stated that (the wire was not going in smoothly, which happens not infrequently, so i pulled the wire back while keeping the needle in the same place).While galt instruction for use number (lab-021-00) stating that under warning section: (do not withdraw guidewire through metal needles; guidewire may shear or unravel) also under caution section stating that: (if resistance is met when advancing or withdrawing the guidewire or the micro-introducer, determine the cause by fluoroscopy and correct before continuing with the procedure) recommendations made to customer and end user through galt failure investigation report stating that (if any obstruction is met, do not attempt to remove guidewires over the needle or other metal instrument.Obstruction might occur during insertion and lead to tangled coiled part of the wire causing difficulty removing wire through tip of the sheath or needle) also (if insertion technique has been failed then remove the wire and the needle (together) and replace them with another new sample to avoid cutting the wire while positioned inside patient body) based on investigation and evaluations this was determined to be end user error (end user did not followed instruction per galt ifu lab-021-00 that shipped along with each product).
Event or Problem Description
As received from end user by manufacturer (i had gotten into a vessel with the micropuncture needle and had inserted the wire thereafter.The wire was not going in smoothly (which happens not infrequently), so i pulled the wire back while keeping the needle in the same place.The tip of the wire was stuck and elongated/unraveled as i pulled back.Subsequently, i pulled everything out (including the needle) from the pt's neck.).

• Brand Name: MICRO-INTRODUCER KIT
• Common Device Name: MICRO-INTRODUCER KIT
• Manufacturer (Section D): GALT MEDICAL CORP.; 2220, 6137, merritt dr, garlan; garland TX 75041
• MDR Report Key: 8388419
• Report Number: 1649395-2019-00003
• Device Sequence Number: 312942
• Product Code: DQX
• UDI-Device Identifier: 20841268104727
• UDI-Public: 20841268104727
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K021990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2019
• Report Date (Section F): 02/11/2019

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: 12/28/2022
• Device Model Number: KIT-002-27
• Device Lot Number: G18362450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/11/2019
• Event Location: Other
• Date Report to Manufacturer: 02/11/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/04/2019
• Patient Sequence Number: 1