MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. PERCUTANEOUS SHEATH / INTRODUCER KIT W/ INTEFRAL HEMOSTASIS VALE / SIDE PORT FOR; INTRODUCER, CATHETER

Model Number	AK-09903-CDC
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Anesthesiologist used steeper angle and got good blood flow in the ij.Wire threaded easily.Ultrasound showing wire in ij.Then crna threaded the cordis over the wire with slight resistance.Upon trying to remove the wire from the introducer, the wire was unraveling.There was little resistance but it kept unraveling as it was pulled out.Since the wire unraveled there was concern that a part of the wire could still be intravascular.Ultrasound was used to look at the vessel.No district signs of the wire but there was something flapping in the vessel which may be a vascular injury.No hematoma in the neck and vessel looks overall intact.Discussed case with cv surgeon and ir.Decision made to do a ct of the chest and neck, introducer was sutured in place, ct revealed retained guidewire and decision made for ir procedure to remove wire.Fda safety report id# (b)(4).

• Brand Name: PERCUTANEOUS SHEATH / INTRODUCER KIT W/ INTEFRAL HEMOSTASIS VALE / SIDE PORT FOR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.
• MDR Report Key: 8735248
• Report Number: MW5087615
• Device Sequence Number: 1680593
• Product Code: DYB
• UDI-Device Identifier: 10801902117417
• UDI-Public: (01)10801902117417
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Voluntary
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

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: Health Professional
• Device Model Number: AK-09903-CDC
• Device Catalogue Number: AK-09903-CDC
• Device Lot Number: 13F19A0303
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization