MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS INTRODUCER; INTRODUCER, CATHETER

Catalog Number RR-AF5A16H

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/28/2022

Event Type  Injury  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k062858, k082644.The actual sample was returned for product evaluation.Visual inspection of the actual sample found that the distal end had been fractured.The total length was confirmed to be 788 mm.As the normal length is 800 mm, it was likely that a portion of 12 mm was missing from the actual sample.Magnifying inspection of the actual sample found that the outer layer had been stretched near the fracture and a part of the core wire was exposed from the outer layer.Electron microscopic inspection of the actual sample found that the outer layer seemed to have been pulled and torn.Electron microscopic inspection of the core wire removed from the outer layer revealed that the distal end had not been deformed in taper and there was radial pattern on the fracture surface.Simulation test/mechanism of the fracture of guidewire.It is known from our past experiments that the guidewire may get fractured when it has been subjected to one of the loads described below, in addition, as for the core wire, the state of the fractured end presents some regularity depending on the fracture mechanism.Continuous one-way torque load to a test sample kept in a curve shape.The fractured ends are not deformed in taper or curved.The fracture surface is flat and radial pattern is observed.This state is similar to that observed on the actual sample.Repetitive bending load at a 90-degree angle.The fractured ends are not deformed in taper or curved, and dimple pattern is observed on the fracture surface.From this, it is presumed that the actual sample was not fractured by this mechanism.One-way pulling load.The fractured ends have been deformed in taper.From this, it is presumed that the actual sample was not fractured by this mechanism.Pulling load to a loop-shaped test sample.The fractured ends have been curved and deformed in taper, and the fracture surface is rough.From this, it is presumed that the actual sample was not fractured by this mechanism.Review of the manufacturing record and the product-release judgement record of the involved product/lot# combination confirmed that there were not any problems in them.A search of the complaint file found no other similar report with the involved product code/lot# combination from other facilities.Based on the investigation results, there was no anomaly in the outer diameter of the actual sample or in the manufacturing history records.From the simulation test results, it was likely that a continuous torque load was applied to the actual sample while it was in the state of being curved, which resulted that the core wire was fractured approximately 12 mm from the distal end due to metal fatigue.After that, it was presumed that the outer layer was torn when the actual sample was pulled out, which resulted in the complete fracture of guidewire inside the patient.(b)(4).

Event Description

The user facility reported that the radiofocus introducer ii h was used for shunt percutaneous transluminal angioplasty (pta).After dilation with a balloon, both the mini guidewire and balloon were removed together, and then the tip of the mini guidewire was found broken.The broken fragment, which had been confirmed near the elbow during the final angiogram, had flowed to the lung.The fragment remained in the patient.The procedure outcome was not reported.The patient was harmed however was not serious.

• Brand Name: RADIFOCUS INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 13901303
• MDR Text Key: 287897205
• Report Number: 9681834-2022-00043
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033681
• 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
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: RR-AF5A16H
• Device Lot Number: 211005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2021
• 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
• Treatment: AC3200 (MEDTRONIC); CK3957 (MEDIKIT); YR45-4020SG (KANEKA)
• Patient Outcome(s): Other