MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION RADIFOCUS GLIDEWIRE ADVANTAGE; WIRE, GUIDE, CATHETER

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/26/2024

Event Type  Injury  

Manufacturer Narrative

G4: pma/510(k): k122590, k163004.Since the actual sample was not returned, investigation of it could not be performed.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar report from other facilities was found in the past complaint file.According to the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.However, since the actual sample was not returned and the analysis of it could not be performed, it was not possible to identify the cause of occurrence.Relevant instructions for use (ifu) reference: "if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire advantage and/or the catheter and determine the cause by fluoroscopy.Continuing to manipulate or rotate the glidewire advantage or failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter, or damage to the vessel." terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the tip of the involved advantage guidewire broke off.The tip of the wire broke in a very calcified artery during crural treatment.Since these crural arteries are very small, the tip of the wire could not be caught and remained in the vessel.A potential risk was the wire could potentially close the vessel.In this case the vessel was already closed due to heavy calcium burden.They did not make an attempt to remove the guide wire tip by surgery.The piece of guide wire was still in the vessel, in occluded segment.The distal end of guidewire was fractured and remained in the patient.The procedure outcome was not reported.The patient was not harmed.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.Visual inspection of the actual sample found that the core wire had been exposed from the distal end to approximately 10mm from the distal end.Magnifying inspection of the actual sample: in the section approximately 10 mm - 20 mm from the distal end, the gold coil was lifted, and the outer layer was twisted.Jumbling of gold coil was found in the section from the distal end to 10 mm from the distal end.No scratches or other external anomaly was found on the other sections.Electron microscopic inspection of the actual sample: the edge of the broken outer layer seemed as if it had been torn off.A fixed size cutting mark (a mark caused in the cutting process of the core wire during manufacturing) was found on the top surface of the core wire, which was similar to that of a current normal sample.Therefore, it was inferred that there was no portion missing from the core wire.Dimensions - outer diameter (undamaged hydrophilic-coated part and undamaged ptfe- coated part): within our control standards with no anomalies.Simulation test: from the condition of the actual sample, it was assumed that an excessive torque load was applied to the relevant section of the actual sample.Based on this assumption, the following simulation test was performed.The distal end of a factory-retained 0.014-inch guidewire advantage was trapped, and continuous one-way torque load was applied to it.As a result, the gold coil near the trapped area became jumbled, and the outer layer became twisted.These characteristics were likely to be similar to those of the actual sample.However, the test sample showed no exposed core wire, which was seen in the actual sample.The fracture of the outer layer and the gold coil observed in the actual sample could not be replicated in this simulation test.This was thought to be due to the degree of load applied to the test sample.Based on the investigation result, no anomaly was found in the manufacturing record, the shipping inspection record, and dimensions of the actual sample.As one of the possibilities for this case, it was inferred that the actual sample was subjected to excessive torque load while its distal end was trapped by some kind of object.Due to this, the gold coil was jumbled, and the outer layer was twisted and torn off.However, since the fracture of gold coil and the outer layer was not replicated during the simulation test, it was not possible to clarify the cause of the exposed core wire.It was considered that approximately 10 mm of the gold coil and the outer layer were missing from the distal section of the actual sample.

• Brand Name: RADIFOCUS GLIDEWIRE ADVANTAGE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 18978974
• MDR Text Key: 338606874
• Report Number: 9681834-2024-00046
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K063372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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: RA*FA14301CM
• Device Lot Number: 231212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2023
• 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): Other
• Patient Age: 83 YR
• Patient Sex: Female