MAUDE Adverse Event Report: TERUMO CLINICAL SUPPLY CO., LTD. PRIORITYONE; CATHETER, EMBOLECTOMY

Model Number	UG1602
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of hypertension, peripheral vascular disease and bradycardia.After presenting to ed with indigestion and heartburn, taken to invasive cath lab for diagnostic heart cath.The priority one catheter was not secure in the loop when taken out of the package.The catheter fell onto the floor; not used on patient.

• Brand Name: PRIORITYONE
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): TERUMO CLINICAL SUPPLY CO., LTD.; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 11580944
• Report Number: 11580944
• Device Sequence Number: 4846442
• Product Code: DXE
• UDI-Device Identifier: 14543334177251
• UDI-Public: (01)14543334177251(17)230531(10)200500730
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/26/2021
• Report Date (Section F): 03/26/2021

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
• Operator of Device: Health Professional
• Device Model Number: UG1602
• Device Catalogue Number: 30-6100
• Device Lot Number: 200500730
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2021
• Patient Sequence Number: 1
• Patient Weight: 108
• Date Report Sent to FDA: 03/26/2021