MAUDE Adverse Event Report: GALT MEDICAL CORP. TRANSITIONLESS MICRO-INTRODUCER KIT; PERCUTANEOUS SHEATH INTRODUCER KIT

Model Number	KIT-038-03
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was prepped/ draped in sterile fashion.Per cardiologist's notes: a percutaneous needle stick was achieved through the left subclavian vein.A guidewire was then inserted into the left subclavian vein.Resistance was met and while retracting the wire, the tip broke off.Contrast angiography was performed demonstrating that the wire was not intravascular.Access was then again achieved via micropuncture under angiography.Manufacturer response for percutaneous sheath introducer kit, transitionless micro-introducer kit (per site reporter).Reported by the cardiac cath lab manager to manufacturer.

• Brand Name: TRANSITIONLESS MICRO-INTRODUCER KIT
• Common Device Name: PERCUTANEOUS SHEATH INTRODUCER KIT
• Manufacturer (Section D): GALT MEDICAL CORP.; 2220 merritt dr; garland TX 75041
• MDR Report Key: 8119529
• Report Number: 8119529
• Device Sequence Number: 16564691
• Product Code: OFL
• UDI-Device Identifier: 00841268104549
• UDI-Public: (01)00841268104549(17)220828(10)G18194884
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2018
• Report Date (Section F): 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: KIT-038-03
• Device Catalogue Number: KIT-038-03
• Device Lot Number: G18194884
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 66
• Date Report Sent to FDA: 11/20/2018