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

Model Number UG1602

Device Problems Device Damaged Prior to Use (2284); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2021

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): TERUMO CLINICAL SUPPLY CO., LTD.; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 11580944
• MDR Text Key: 242700141
• Report Number: 11580944
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 14543334177251
• UDI-Public: (01)14543334177251(17)230531(10)200500730
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UG1602
• Device Catalogue Number: 30-6100
• Device Lot Number: 200500730
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31755 DA
• Patient Weight: 108