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

Model Number	N/A
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: lead tech.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 number combination was conducted with no findings.
Event or Problem Description
The user facility reported that the 6fr pinnacle sheath seemed to be tight and restrictive to the 6f catheter that was used with it during the case.The patient was stable, and the outcome of the procedure was a success.Additional information was received on 30 dec 2022: the procedure was a coronary angioplasty.Procedure was completed using the sheath, it was just very tight trying to advance and manipulate the catheter through the sheath.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.This report has been deemed not reportable based off of the investigation of the actual sample.One 6fr ik sheath and dilator were returned for product evaluation.Two 6fr medtronic launcher catheters were also returned to be assessed with the ik sheath and dilator.The sample was returned with the dilator inserted into the sheath.The sample was subject to visual analysis.No bends, cracks, or deformations were observed on the sheath or dilator.The catheters were inserted into the sheath.Both catheters were inserted without resistance.The catheters are marked as eb35 and eb40.The sheath internal diameter (id) was measured and the max pin gauge that would pass without resistance is.084in.The dilator outer diameter (od) was measured to be.0824 -.0826in.The catheter outer diameter (od) was measured for each catheter.Catheter eb35 was measured to be.0825-.0830in ( and catheter eb40 was measured to be.0825-.0830in.The complaint cannot be confirmed for mobility issues because the failure mode could not be replicated on the returned sample.The exact root cause could not be determined.The likely root cause is the catheters are larger than specification, preventing them from being inserted into the sheath.Review of device history record (dhr) showed there were no issues noted during manufacture of the product that could have contributed to this complaint condition.Currently no action is recommended since this risk evaluation is within the predetermined limits in the failure mode & effects analysis (fmea).

• Brand Name: RADIFOCUS INTRODUCER II KIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: gina digioia ; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 16245818
• Report Number: 1118880-2022-00109
• Device Sequence Number: 17797816
• Product Code: DYB
• UDI-Device Identifier: 00389701007250
• UDI-Public: 00389701007250
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2025
• Device Model Number: N/A
• Device Catalogue Number: RSS601
• Device Lot Number: 0000241611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6FR CATHETER
• Patient Age: 67 YR
• Patient Sex: Male