MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION RADIFOCUS INTRODUCER II KIT; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
Terumo medical received a user facility medwatch report # 1000870000-2020-8062.The event description states: "during an ep study with ambulation the sheath was introduced to the right femoral vein.When the wire and dilator were pulled back, the sheath valve came off.The patient was bleeding back from the sheath, and the doctor replaced the sheath with a new fr 10cm terumo sheath.The procedure was completed without complications.The date of the event is august 2020." additional information was received on 14september2020: the blood loss was less than 250cc's.Three sheaths were inserted into the rfv (9,8,7fr) using ultrasound guidance.An 8fr intracardiac echocardiography catheter was inserted and advanced into the right atrium.Intracardiac echocardiography was performed, and was later used to guide the transseptal puncture.A decapolar diagnostic catheter was advanced to the coronary sinus for left atrial pacing and recording.Catheters/wires were advanced to the heart under fluoroscopic guidance.The right femoral venous 8fr sheath was exchanged over a wire for a medium curl agilis.Additional information was received per medwatch on 18september2020: "patient problems: hemorrhage/bleeding.".
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: RADIFOCUS INTRODUCER II KIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 10627748
• Report Number: 1118880-2020-00237
• Device Sequence Number: 3205445
• Product Code: DYB
• UDI-Device Identifier: 00389701007502
• UDI-Public: 00389701007502
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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 Expiration Date: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: RSS902
• Device Lot Number: YC12
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: A DECAPOLAR DIAGNOSTIC CATHETER.; AN 8FR INTRACARDIAC ECHOCARDIOGRAPHY CATHETER.; CATHETERS/WIRES, 8FR SHEATH.; THREE SHEATHS (9,8,7FR).; A DECAPOLAR DIAGNOSTIC CATHETER.; AN 8FR INTRACARDIAC ECHOCARDIOGRAPHY CATHETER; CATHETERS/WIRES, 8FR SHEATH; THREE SHEATHS (9,8,7FR)
• Patient Age: 81 YR
• Patient Weight: 83