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	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation per health professional.Investigation and evaluation performed based on device history review and complaint history review.Device history review shows all units was manufactured to specifications and passed inspection criteria.Based on history record for last five years, this type of incident might occur due to end user error.End user might not follow instructions per (instructions for use).Per health professional statement said (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).Guidewires cannot be removed from patient body through the needle.If any obstructions or resistance occurred it is recommended to remove entire assembly from patient body not only the guidewires.Removing guidewires through the needle might lead to cut tip of coiled wire by cutting edges of the needles or guidewires might unraveled or tangled while inside patient body causing serious injury.Manufacturer recommend to end user to follow instruction for use stated as warning (do not withdraw guidewire through metal needles; guidewire may shear or unravel).
Event or Problem Description
As received from health professional: 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.

• Brand Name: TRANSITIONLESS MICRO-INTRODUCER KIT
• Common Device Name: PERCUTANEOUS SHEATH INTRODUCER KIT
• Manufacturer (Section D): GALT MEDICAL CORP.; 2220, 6137, merritt dr; garland TX 75041
• MDR Report Key: 8171754
• Report Number: 1649395-2018-00010
• Device Sequence Number: 16508573
• Product Code: OFL
• UDI-Device Identifier: 20841268104543
• UDI-Public: 20841268104543
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2018
• Report Date (Section F): 11/30/2018

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: 08/28/2022
• Device Model Number: KIT-038-03
• Device Catalogue Number: KIT-038-03
• Device Lot Number: G18194884
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Weight: 66
• Date Report Sent to FDA: 11/30/2018