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

Model Number	N/A
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 #: 2300170000-2019-8015.The event description states: "approximately 2 month ago, we were placing a 5fr pinnacle after using a micro puncture for groin access.We had fed the wire from the pinnacle through the introducer of the micro puncture which appeared to go just fine.Upon feeding the sheath over the wire, it was observed that the sheath would not advance.Sheath was removed and wire appeared to be stuck to the subcutaneous tissue.Dr.Attempted to remove the wire, realizing that it was stuck and not budging he called another doctor to assist.The doctor was successful in removing the wire all in one piece.Visualizing the wire post removal there are two kinks.This happened during the original intended procedure of a diagnostic cerebral angiogram".Additional information was received on 04sept2019.The patient was discharged.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section d10 and 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: 9083800
• Report Number: 1118880-2019-00249
• Device Sequence Number: 14128294
• Product Code: DYB
• UDI-Device Identifier: 00389701007465
• UDI-Public: 00389701007465
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/18/2019

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: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: RSS502
• Device Lot Number: XC13
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1