MAUDE Adverse Event Report: GALT MEDICAL CORP 4F TRANSITIONLESS MICRO-INTRODUCER KIT (SILK ROAD #SR-4F21G7D-MP); TRANSITIONLESS MICRO-INTRODUCER KIT KIT-075-03

Model Number	KIT-075-03
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As received from the customer (it was reported by end user that on (b)(6) 2021, during a tcar procedure, microware was advanced through needle only a couple of inches.Microdilator was then used.When removing dilator and wire, wire would not come back.Wire was stuck and floppy tip was frayed and was stuck in patient.Physician had to open artery to remove wire.Patient status is stable).
Additional Manufacturer Narrative
Complaint sample has not been returned yet, galt initiate rma for the customer in order to send the sample back for evaluation.Device history record has been reviewed and there are no incidents or abnormality indicated, all units including subcomponents manufactured to specification without any deviations.This complaint will remain open per internal procedure until sample will be received and a follow report will send to fda including rot cause and resolutions if needed.
Additional Manufacturer Narrative
Complaint sample has not been returned yet, galt initiate rma for the customer in order to send the sample back for evaluation.Device history record has been reviewed and there are no incidents or abnormality indicated, all units including subcomponents manufactured to specification without any deviations.This complaint will remain open per internal procedure until sample will be received and a follow report will send to fda including rot cause and resolutions if needed.Update 1/13/2022: regarding the customer nonconformance (customer reference (b)(4), only the wire gwa-038-24 returned back and photos has been taken as shown in failure investigation report.Dhrs has been reviewed, there was no abnormality or nonconformance recorded during manufacturing process.Galt filed mdr initial report to fda on 12/6/2021.This is follow-up to original report number (b)(4).Some photos taken for returned samples shows distal coiled portion of the wire has been separated and unraveled, core wire twisted and cut due to overtorque and the coils of the wire unraveled.Possible root cause for this occurrence; end user error.End user might apply excessive pull force on the wire to remove it from patient body while the needle was in place.Unravelling coiled portion of the wire occurs normally when guidewires remove from the patient body while the needle is still in place, this unravelling may lead end user to apply excessive pull force to remove the wire from patient body causing damage tip of the wire or sometimes cutting the wire to multiple pieces by the needle.Possible root cause for this occurrence determined to be end user error.End user did not followed ifu.Ifu (lab-919-01, rev (c) page (1) under warning stated (do not withdraw guidewire through metal needles; guidewire may shear or unravel).
Event or Problem Description
As received from the customer (it was reported by end user that on (b)(6) 2021, during a tcar procedure, microware was advanced through needle only a couple of inches.Microdilator was then used.When removing dilator and wire, wire would not come back.Wire was stuck and floppy tip was frayed and was stuck in patient.Physician had to open artery to remove wire.Patient status is stable).

• Brand Name: 4F TRANSITIONLESS MICRO-INTRODUCER KIT (SILK ROAD #SR-4F21G7D-MP)
• Common Device Name: TRANSITIONLESS MICRO-INTRODUCER KIT KIT-075-03
• Manufacturer (Section D): GALT MEDICAL CORP; 2220 merritt dr #100; garland 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: 12940648
• Report Number: 1649395-2021-00008
• Device Sequence Number: 4884245
• Product Code: OFL
• UDI-Device Identifier: 10841268107257
• UDI-Public: 10841268107257
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: Other,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2021

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
• Device Expiration Date: 10/28/2024
• Device Model Number: KIT-075-03
• Device Lot Number: G20251056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown