MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE; INTRODUCER, CATHETER

Model Number	RSS902
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Incident description: sheath introduced to right femoral vein (rfv).When wire and dilator were pulled back, the sheath valve came off.Patient was bleeding back from sheath, and the doctor replaced the sheath with a new 9fr 10cm terumo sheath.The procedure was completed without complications.

• Brand Name: PINNACLE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 10476209
• Report Number: 10476209
• Device Sequence Number: 19471092
• Product Code: DYB
• UDI-Device Identifier: 00389701007502
• UDI-Public: (01)00389701007502(17)220731(10)YC12
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/24/2020
• Report Date (Section F): 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RSS902
• Device Catalogue Number: RSS902
• Device Lot Number: YC12
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 83
• Date Report Sent to FDA: 08/24/2020