MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA PROGREAT CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	MC*PC2013Y
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical received fda medwatch report (b)(4).The event description states: "while removing the fathom wire through the pro great microcatheter, part of the tip of the wire (7-10cm) broke off in the artery and was unable to be removed despite attempt via snare.What was the original intended procedure: y 90 radioembolization.Selective catheterization celiac artery for celiac artery angiogram.Original intended procedure: superselective catheterization of the right hepatic artery for right hepatic artery angiogram and coned beam ct.Cone beam dyna ct with catheter positioned in hepatic arteries with additional 3-d image postprocessing.Transarterial delivering y90 sirshpheres in superselective right hepatic artery.Ultrasound guidance for arterial access.Limited right common femoral artery angiogram and closure device deployment for hemostasis.".
Additional Manufacturer Narrative
B3: date of event: june 2024.E3: occupation: risk 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 from other facilities was found in the past complaint file.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
Additional information was received on 21jan2025: the tip of the guidewire remains inside of the patient's vessel.The patient was stable and there appears to be no long lasting issue.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the additional information in section b3 and section b5, to update section d9 and to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The yield rate at the time of final visual inspection of the product with the involved product code/lot number in the manufacturing process was investigated.- when compared with nearby lots, no reduction in yield rate was observed.(cause of occurrence).Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.Regarding "part of the tip of the wire (7-10cm) [combined device] broke off" that was described in the fda form, since the actual sample was not returned and investigation of it could not be performed, it was not possible to clarify the causal relationship between the breaking off of the actual product and the guidewire.(countermeasure).Ashitaka factory has been making efforts in maintaining the quality of the product by performing following work and inspections.- the product is always flowed in the production process with a core wire inserted in the lumen to assure the catheter lumen.- after the product assembling process, a core wire conforming to the maximum applicable guidewire is inserted over the entire length of the catheter, and 100% insertion inspection is performed.- before the product packaging process, 100% visual inspection is performed to confirm that there is no anomaly such as a kink or crush.(b)(4).

• Brand Name: PROGREAT CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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 ; 9499890491
• MDR Report Key: 20914014
• Report Number: 9681834-2024-00226
• Device Sequence Number: 15398348
• Product Code: DQO
• UDI-Device Identifier: 04987350727367
• UDI-Public: (01)04987350727367(17)250930(10)231018
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K033583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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 Expiration Date: 09/30/2025
• Device Model Number: MC*PC2013Y
• Device Catalogue Number: MC*PC2013Y
• Device Lot Number: 231018
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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: BOSTON SCIENTIFIC FATHOM GUIDEWIRE.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown