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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the glidewire gold broke off inside of a quickcross catheter during the procedure.There was no patient injury/medical or surgical intervention required.The patient was in stable condition.They were able to remove the catheter with wire and continued the case.Additional information was received on 06jul2023: the procedure being performed was a lower extremity angiogram.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided due to hospital policy.A2: age & date of birth: requested, not provided due to hospital policy.A3: patient sex: requested, not provided due to hospital policy.A4: weight: requested, not provided due to hospital policy.A5: ethnicity: requested, not provided due to hospital policy.A6: race: requested, not provided due to hospital policy.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.Since the actual sample was not returned, investigation of it could not be performed.History investigation of the involved product code/lot number: - no anomaly was found in the manufacturing record and the shipping inspection record.- no other similar report from other facilities was found.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.Ashitaka factory assures the quality of this product by performing following inspections and control.To assure the strength of core, the outer diameter of it is controlled.Before the packaging process, 100% visual inspection is performed to confirm that there is no anomaly such as a scratch or peeling of outer layer.The ifu of this product indicates the following warning: [warning] "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.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• 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 ; 6402040886
• MDR Report Key: 17355869
• Report Number: 9681834-2023-00143
• Device Sequence Number: 6011359
• Product Code: DQX
• UDI-Device Identifier: 04987350711908
• UDI-Public: 04987350711908
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/19/2023

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: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: GM1831
• Device Lot Number: 220127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: QUICKCROSS
• Patient Sex: Unknown