MAUDE Adverse Event Report: GALT MEDICAL CORP GALT MICRO-INTRODUCER KIT; PERCUTANEOUS SHEATH INTRODUCER KIT KIT-038-02

Model Number	KIT-038-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As received by email on (b)(6) 2022 under mdr report number (b)(4) from fda, division of surveillance support, medical device reporting team "micro puncture kit was used for getting access during procedure.Piece of wire broke off in patient.It was able to be retrieved but there was a portion of the plastic sheath that was left in the patient.Fda safety report id# (b)(4)".
Additional Manufacturer Narrative
Device history record reviewed for main product micro introducer kit and the subcomponent 0.018x40cm ss core w/7.0cm au-pltd w coil guidewire, and there are no incidents or abnormalities indicated.All units were manufactured to specifications according to engineering drawing and quality control criteria.The device has not been return yet, a follow-up report will be send to fda once complaint device or complaint sample returned to manufacturer and once investigation and evaluation will be completed.
Event or Problem Description
This is a follow up report for original report sent to cdrh on 7/15/2022.Initial report is under mdr report key (b)(4).At the time of initial report, there were no samples available for evaluation, and now samples returned to manufacturer on 8/2/2022.
Additional Manufacturer Narrative
Investigation per dhrs shows no abnormality or nonconformance was recorded during product manufacturing and assembly.Manufacturer filed initial mdr report to fda under galt report number (1649395-2022-00003).Device history record reviewed for main product micro introducer kit and the subcomponent 0.018x40cm ss core w/7.0cm au-pltd w coil guidewire, and there are no incidents or abnormalities indicated.All units were manufactured to specifications according to engineering drawing and quality control criteria.Regarding the customer's nonconformance, the complaint sample returned, and the quality team took some photos for evaluations.The subject device (guidewires) returned, and the tip has been inspected, it shows not damages occurred after wire extracted from the patient body.Distal tip measured at (0.0180") and measurement within spec per engineering drawings.Some images were taken and shows wire broken from core portion near distal tip.Evaluation on returned sample shows possible root cause for this occurrence was end user error due to excessive torque force by end user while the wire still inside the patient.Other subcomponents returned along with subject device.The subcomponents that were returned was inner dilator and outer dilator.Id through hole for outer dilator measured and it shows within spec per engineering drawings, and id through hole for inner dilator measured and it shows within spec per engineering drawings as well.The image for outer dilator appears how tube exposed to sever damages from various areas; possible root cause end user used unknown device to extract the assembly from the patient body.Inner dilator with damage at the tip portion as well.After cleaning inside tube from blood clots, the guidewire passes through inner dilator smoothly.The guidewire measured at 0.0175" and measurement is within spec per manufacturer's engineering drawings.After investigation and evaluation, it was determined that possible root cause for this occurrence is end user error.

• Brand Name: GALT MICRO-INTRODUCER KIT
• Common Device Name: PERCUTANEOUS SHEATH INTRODUCER KIT KIT-038-02
• Manufacturer (Section D): GALT MEDICAL CORP; 2220 merritt dr #100; garland TX 75041
• Manufacturer (Section G): GALT MEDICAL CORP; 2220 merritt dr #100; garland TX 75041
• Manufacturer Contact: diyar medhat ; 2220 merritt dr #100; garland, TX 75041 ; 9722715177
• MDR Report Key: 15028537
• Report Number: 1649395-2022-00003
• Device Sequence Number: 12319753
• Product Code: OFL
• UDI-Device Identifier: 00841268104532
• UDI-Public: 00841268104532
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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
• Device Expiration Date: 08/05/2026
• Device Model Number: KIT-038-02
• Device Catalogue Number: KIT-038-02
• Device Lot Number: G21330170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2022
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown