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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has 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
The user facility reported that the ik device valve appeared to be leaking, in addition there were air bubbles noticed inside the port when a syringe was used to pull blood back for a act purposes.This 9 french sheath was used for a electrophysiology (ep) procedures, in addition three additional sheaths of various sizes such as a 8fr were used.The patient was in stable condition and the procedure was satisfactory.The blood loss was less than 250cc's.An i.C.E.Ep catheter was placed in the 9 french sheath.There was no patient injury, medical/surgical intervention required.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to correct section d10, to correct section h3, and to provide the completed investigation results.In the initial report it was report that the sample was returned however there was only one sample returned.Please see related report mdr 11188802020-00170 which was the first device used on the same patient.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
• MDR Report Key: 10319602
• Report Number: 1118880-2020-00171
• Device Sequence Number: 2679285
• Product Code: DYB
• UDI-Device Identifier: 00389701007502
• UDI-Public: 00389701007502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K954234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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?: No
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/21/2020
• 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: 6 FR SHEATH & 5 FR. SHEATH; I.C.E. EP CATHETER, 8 FR. SHEATH
• Patient Age: 74 YR