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

Model Number	GM1831
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the tip of the glidewire gold broke off inside the patient.They were able to retrieve the tip out of the patient.There was calcium in the patient's artery, and the way the wire was manipulated caused it to break off.There was no estimated blood loss.There was no surgical intervention required.There was no direct allegation that the reported device caused or contributed to patient injury.Additional information was received on 30oct2023: the procedure was a peripheral.A snare was used to remove the broken tip.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual sample was not available; therefore, investigation of it could not be performed.History investigation of the product with the involved product code/lot number found no anomaly in the manufacturing record and the shipping inspection record.No other similar report from other facilities 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 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 inspection and control.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 anomaly such as a scratch or peeling of the outer layer.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." please see mdr 2243441-2023-00041 for the importer report.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 a correction to section d1: brand name, section d4: udi, model number, and the catalog number.

• Brand Name: GUIDE WIRE M
• 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: 18148582
• Report Number: 9681834-2023-00239
• Device Sequence Number: 7609180
• Product Code: DQX
• UDI-Device Identifier: 04987350711908
• UDI-Public: (01)04987350711908(17)241130(10)221213
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 11/30/2024
• Device Model Number: GM1831
• Device Catalogue Number: RF*RA18303TA
• Device Lot Number: 221213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• 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: Required Intervention; Other
• Patient Sex: Unknown