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

Model Number	GA1430
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the procedure was a right leg atherectomy.The wire started backing out while taking the bd rotarex out of the patient.The device came out, they took pictures, and removed the wire.The wire was broken.The wire made it to the sheath before it broke all the way off.They retrieved the wire with no complications.They did not have to use a snare; it came out with the sheath.The case was successful, and the patient did not know anything was wrong.They stated they use the rotarex all the time over the gwa.The blood loss was less than 250cc's.The reported event did not result in patient injury and/or require medical or surgical intervention.Additional information was received on 23sep2024: the patient was stable.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted, d6b: explanted date: device was not explanted, e3: occupation: bsn rn-director of operations.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.No anomaly was found in the manufacturing record and the shipping inspection record.No anomaly was found in the manufacturing record and the shipping inspection record.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The actual sample has not been returned to ashitaka factory.Therefore, an evaluation of the actual device was unable to be conducted.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past.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 confirmed, it was not possible to clarify the cause of occurrence.Ashitaka factory has been making efforts in maintaining the quality of the product by performing following controls.The outer diameter of product is controlled.In the product assembling process, 100% visual inspection is performed to confirm that there is no anomaly in its appearance.The instructions for use (ifu) of this product includes the following warning."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.".

• Brand Name: GLIDEWIRE ADVANTAGE
• 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, NJ 08873 ; 4103927218
• MDR Report Key: 20397253
• Report Number: 9681834-2024-00176
• Device Sequence Number: 6479925
• Product Code: DQX
• UDI-Device Identifier: 04987350717924
• UDI-Public: (01)04987350717924(17)251130(10)231201
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K122590
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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: 11/30/2025
• Device Model Number: GA1430
• Device Catalogue Number: RA*FA14301C
• Device Lot Number: 231201A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 035 GWA ANGIOSEAL; 5FR MERIT SHEATH; 6FR BIOTRONIK 65CM SHEATH; NAVICROSS 035 135CM; ROTAREX; VERT CURVED ANGIODYNAMICS CATHETER
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 190 KG
• Patient Race: Black Or African American