MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 other similar report was found in the past complaint file.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).
Event or Problem Description
The user facility reported during a diagnostic panangiography, the glide cath xp catheter device was used, through radial access.During the procedure, after obtaining images the catheter does not respond to torque when manipulating.Two kinks were observed (distal and proximal in the catheter).Hydrophilic guide was advanced to be able to remove the catheter, which deformed.The pain during catheter removal in the right arm requires anesthesia assistance for sedation.There were no additional complications.The patient experienced pain during removal of the product and was treated with anesthesia.The procedure outcome was not reported.The patient was harmed; however, not seriously.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.Ashitaka has requested our local branch to update the status of the actual sample.However, we have not received any additional information, therefore, ashitaka made the decision to make the answer card without the sample on (b)(6) 2024.From the provided image, it was found that the shaft was kinked.The guidewire was not inserted into the involved section.Since no actual sample was 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 was found in the past.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.From the provided image, as a possible cause of this case, it was inferred that when the guidewire was not inserted into the actual product, some bending force was applied, causing the product to kink.However, since the actual sample could not be investigated, and the details of procedure were unknown, it was not possible to identify the cause of occurrence.

• Brand Name: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• 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: 19749537
• Report Number: 9681834-2024-00117
• Device Sequence Number: 15086081
• Product Code: DQO
• UDI-Device Identifier: 04987350767516
• UDI-Public: (01)04987350767516(17)261031(10)231102
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K090040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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 Model Number: N/A
• Device Catalogue Number: RF*WA25110M
• Device Lot Number: 231102
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• 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: HYDROPHILIC GUIDEWIRE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female