MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. ARROWG+ARD BLUE MAC CATHETER ; INTRODUCER, CATHETER

Model Number	IPN036349
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
During an attempted femoral vein cannulation with an arrowg+ard blue mac catheter, the femoral artery was damaged.The pt's leg required surgical amputation as a complication of the vascular injury.Our subsequent stimulation of the device insertion demonstrated that the dilator can puncture the posterior vessel wall, potentially damaging adjacent structures, when the guidewire is not inserted to sufficient depth.Under these conditions, the sharp tip of the dilator is not protected by protruding guidewire and can directly contact and penetrate the posterior vessel wall.Without sufficient wire to guide it, the dilator follows a straight trajectory from the skin surface increasing the likelihood that it will penetrate the posterior vessel wall, rather than following the vessel lumen.The mfr does not provide instructions on appropriate guidewire insertion depth, and the guidewire is not marked to indicate appropriate insertion depth.The 45cm guidewire provided in the kit may contribute to the risk of this complication; a longer (60cm) guidewire is provided in a triple-lumen catheter by the same mfr.The 45cm guidewire does not provide sufficient length within the target vessel if the operator allows greater than approx 10cm of guidewire external to the pt, to prevent the wire from embolizing into the pt, including this case, we have observed 3 similar cases in the past year in our institution associated with this device, resulting in 3 arterial injuries, 2 strokes, one limb amputation, and one death.Ref mw5093647, mw5093667.Fda safety report id# (b)(4).

• Brand Name: ARROWG+ARD BLUE MAC CATHETER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.
• MDR Report Key: 9818302
• Report Number: MW5093666
• Device Sequence Number: 2855846
• Product Code: DYB
• UDI-Device Identifier: 10801902141122
• UDI-Public: (01)10801902141122
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN036349
• Device Catalogue Number: ASK-21242-DU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2020
• 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; Life Threatening; Other; Required Intervention; Disability