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

Model Number N/A

Device Problem Difficult to Advance (2920)

Patient Problem Hematoma (1884)

Event Date 06/16/2023

Event Type  Injury  

Event Description

The user facility reported that the sheath could not be advanced into the femoral artery for neuroradiological intervention.The patient's stature can be described as normal, not overweight.The puncture and the insertion of the enclosed wire went smoothly.The dilator was inserted into to the sheath as usual with a "click" sound.The sheath could be pushed over the skin barrier to the vessel with the dilator.Then the dilator separated from the sheath.Dilator and sheath was again clicked together.However, insertion into the vessel was not possible.The process was repeated with the same product from the same lot in the same patient, unfortunately without success.The intervention could be completed with an alternative sheath (other size).The patient was not harmed.Intervention left a hematoma at the puncture site that was controllable over time with no consequences for the patient.

Manufacturer Narrative

A1: patient identifier: requested, not provided due to safety reasons of the hospital a2: age & date of birth: requested, not provided due to safety reasons of the hospital a4: weight: requested, not provided due to safety reasons of the hospital a5: ethnicity: requested, not provided due to safety reasons of the hospital a6: race: requested, not provided due to safety reasons of the hospital d6a: implanted date: device was not implanted d6b: explanted date: device was not explanted a review of the device history record of the product code/lot number combination was conducted with no findings.The actual device was not available for returned; therefore, an evaluation of the actual device will not be conducted.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.

Event Description

Additional information was received on 08aug2023: the french size used to successfully complete the procedure was a 6fr sheath size.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information to section b5, to provide the device return date in section d9 and to update section h3.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.

Manufacturer Narrative

This report is being sent as follow-up no.2 to correct section d9, to update section h3, 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.The complaint cannot be confirmed for insertion difficulties because the sample was not returned for assessment.Without a sample, the exact root cause cannot be determined.The likely root cause is the wrong sheath size was selected for the access site, preventing the user from inserting the device into the patient.Review of the 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 the risk evaluation is within the predetermined limits in the design failure mode and effects analysis (dfmea).

• Brand Name: RADIFOCUS INTRODUCER II KIT
• Type of Device: 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: 17330410
• MDR Text Key: 319094029
• Report Number: 1118880-2023-00365
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RSB50N10MRD
• Device Lot Number: 0000275888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 08/08/2023; 09/08/2023
• Supplement Dates FDA Received: 09/07/2023; 10/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male