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	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was 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.This report is for the second device used on the patient; see mdr no.1118880-2019-00005 for the first device reported.
Event or Problem Description
The user facility reported that the ik femoral sheath kinked during the procedure causing damage to the 6fr cello (penumbra) guide catheter.The sheath was replaced with another 6fr pinnacle however, also kinked.The user reported that the sheath felt thinner so they used another device, which was fine.The procedure was finished successfully with the new device and there was an approximately five minute delay in completing the procedure to do the sheath exchanges.The patient was in good condition.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The evaluation of the actual device could not be conducted due to the device not being returned.With no device return, the exact cause of the reported event cannot be definitively determined based on the available information.
Event or Problem Description
Additional information was received january 31, 2019: the procedure that was performed was a neuro coiling.The patient was stable.The procedure outcome was successful.

• 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: 8260710
• Report Number: 1118880-2019-00005
• Device Sequence Number: 2056928
• Product Code: DYB
• UDI-Device Identifier: 00389701007649
• UDI-Public: 00389701007649
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K954234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: RSS604
• Device Lot Number: WF23
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 02/11/2019
• 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: 6FR CELLO GUIDE; 6FR CELLO GUIDE