MAUDE Adverse Event Report: GALT MEDICAL CORP MICRO-ACCESS TEARAWAY INTRODUCER KIT; PERCUTANEOUS SHEATH INTRODUCER KIT

Model Number	KIT-010-14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	12/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Galt medical corporation received medwatch 3500a form report from fda by email under title mdr report: (b)(4).Description of the problem stated (rn was placing a new poly midline.After accessing the vein and threading the guidewire, rn attempted to insert a drop in galt introducer.A small nick was made prior to attempting to place dilator/introducer, however, despite sufficient nick in skin, the introducer would not advance past the peel-able sheath.Additional small nick made, and dilator/introducer attempted again, but still unable to advance past peel-able sheath.Introducer removed again and inspected for defect.Upon inspection, sheath noted to have defect and was curled and/or peeled back at the tip.As a result, the patient experienced mild pain/discomfort and mild/moderate amount of blood loss.A celox patch was placed, and pressure held at site for approximately 5 minutes before dressing applied).
Additional Manufacturer Narrative
Sample will not be returned by distributor or end user.Investigation and evaluation performed based on device history record review, complaint history record review, failure mode and effective analysis review, risk management report for related product family review.Device history record reviewed for main product and subcomponents and found all products manufactured to specification without any deviation or abnormality indicated.Complaint history record reviewed and found there are no complaints from the field against subject device kit-010-04 last five years.Complaint history record reviewed and found there are 59 records received from customer and/or end user regarding failure category (buckle tip of the sheath).16 records show samples returned and complaint confirmed.Other records show complained unconfirmed due to unavailability of complaint samples.None of 16 complaints previously received has broken tips.Evaluation on previous complaints shows root cause of the incident was end user error as majority of the units sold as bulk non-sterile.Subject device in this report sold as sterile product.End user will be notify to adhere to ifu.

• Brand Name: MICRO-ACCESS TEARAWAY INTRODUCER KIT
• Common Device Name: PERCUTANEOUS SHEATH INTRODUCER KIT
• 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: 16358063
• Report Number: 1649395-2023-00002
• Device Sequence Number: 12341950
• Product Code: OFL
• UDI-Device Identifier: 10841268105130
• UDI-Public: 10841268105130
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: KIT-010-14
• Device Lot Number: S22356809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2022
• 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): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Race: White