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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided a2: age or date of birth: requested, not provided a3a: sex: requested, not provided a3b: gender: unknown a4: weight: requested, not provided a5: ethnicity: requested, not provided a6: race: requested, not provided d6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e3: occupation: material the actual sample was not available.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.Based on 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 investigation of it could not be performed, it was not possible to identify the cause of occurrence.Ashitaka factory assures the quality of this product by performing following inspections and control.Through eddy current flaw detection*, it is confirmed that there is no crack in the wire over the entire length.The outer diameter of wire is controlled to assure the strength of wire.Before the packaging process, 100% visual inspection is performed to confirm that there is no peeling of the outer layer or no scratch in the appearance.*eddy current flaw detection: when an alternating current is passed through a coil, a magnetic field is generated in the direction perpendicular to the current.When the coil is brought close to the conductor (core wire), an eddy current is generated on the surface of the conductor.If any anomaly including a crack is generated in the conductor, the eddy current avoids the crack and flows around the conductor, so that the flow changes as compared with the case where there is no crack.The method of detecting changes in the flow of eddy currents and searching for cracks is called eddy current flaw detection.Instructions for use (ifu) of this product includes the following warning: "[warnings] if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the[?]glidewire and/or the catheter and determine the cause by fluoroscopy.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).For the importer report for this reported event please see mdr 2243441-2024-00010.
Event or Problem Description
The user facility reported that when torquing the involved guidewire (gw), the distal angled portion of the gw broke off and remained in the patient.There was no blood loss.The reported event resulted in patient injury and/or require medical or surgical intervention.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.Additional information was received on 16apr2024: the procedure performed was a bilateral pelvic angiogram.There was no intervention performed when the wire broke off, the physician was attempting to cross a lesion.There was no more resistance than what was to be expected.The broken piece was not removed from the patient, it was in the retroperitoneal soft tissue.The piece remained in the patient.The patient was stable.The procedure was not completed at that time due to patient tolerance.The patient needed anesthesia and the procedure was completed a different day with general anesthesia.The device did not appear to be damaged prior to use.

• Brand Name: RADIFOCUS GUIDEWIRE
• Common Device Name: 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: 19220610
• Report Number: 9681834-2024-00070
• Device Sequence Number: 15184211
• Product Code: DQX
• UDI-Device Identifier: 04987350773593
• UDI-Public: 04987350773593
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K863138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: N/A
• Device Catalogue Number: GS3506
• Device Lot Number: 231117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown