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

Model Number	GM1831
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: lead tech/lab manager.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.History investigation of the involved product code and lot number no anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past complaint file.Udi no.: (b)(4).Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
The user facility that the glidewire gold was being used in conjunction with the 108 navicross and it began to get a little sticky inside the microcatheter and then when they pulled the wire out.There was a lot of tension, the wire had separated and exposed the core of the wire and the coating was pulled off.The procedure type was an lower extremity (le) angiogram.There was no blood loss and the patient was stable.Additional information was received on 09oct2024: the wire was used in the patient's body and there was no infectious agents nor anti-cancer agents.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9 and to provide the completed investigation results.The actual device was returned for product evaluation.1.A guidewire (actual sample) was returned.2.Visual inspection of the actual sample (unaided eye and digital microscope) the outer layer had been turned inside out and folded back over itself in the area approximately 25 mm - 35 mm from the distal end.Exposed core wire was observed in the area approximately 35 mm - 45 mm from the distal end.Since both the folded-back part of the outer layer and the exposed core wire were 10 mm long, it is probable that there was no missing section.No anomalies, such as scratched or peeling of outer layer, were found in other areas.3.Dimensions: the outer diameter (undamaged section) met the factory's control standards.No anomaly was observed.4.Simulation test using a factory-retained sample: a guidewire was inserted into a catheter and intentionally abraded the outer layer.Subsequently, when removing the guidewire from the catheter, the abrasion area became caught on the catheter.Despite this, the operation to remove it continued, resulting in the folding back of the outer layer in the distal direction.It was thought that this condition resembled that of the actual sample.(cause of occurrence): based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.One possibility that was inferred is that the actual sample may have been in contact with a hard object and abrasions were made on the outer layer.When the actual sample in this state was removed from the catheter, it was likely that the abrasions became caught on the catheter, which resulted in the folded-back outer layer towards the distal direction.However, since the details of the procedure were unknown, it was not possible to clarify exactly when the event occurred.(countermeasure): ashitaka factory is always making efforts to maintain the product quality by performing the following controls.The guidewire is passed through the dedicated tool on 100% basis to confirm that there is no peeling of the outer layer on the surface of guidewire.In the product assembling process, 100% visual inspection is performed to assure that there is no anomaly in the appearance including abrasions.The ifu of this product indicates as follows.If any resistance is felt or if the tip's behavior and/or location seems improper,stop manipulating the glidewireadvantage and/or the catheter and determine the cause by fluoroscopy.Continuing to manipulate or rotate the glidewireadvantage 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.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: RADIFOCUS GUIDEWIRE M
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya 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 ; 265 davidson ave; suite 320; somerset 08873 ; 9499890491
• MDR Report Key: 20605832
• Report Number: 9681834-2024-00191
• Device Sequence Number: 7929036
• Product Code: DQX
• UDI-Device Identifier: 04987350711908
• UDI-Public: (01)04987350711908(17)251231(10)240119
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 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): 11/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: GM1831
• Device Catalogue Number: RF*RA18303TA
• Device Lot Number: 240119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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: DESTINATION.; GILDEWIRE GOLD.; NAVICROSS 018.
• Patient Sex: Unknown