MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA FINECROSS; CATHETER, CONTINUOUS FLUSH

Model Number	35-1450
Medical Device Problem Codes	Material Separation (1562); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: date of birth: requested, not provided.D4: lot number: requested, not provided.D4: expiration date: unknown, as the involved lot number was not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: rn, bsn, patient safety nurse coordinator ii.H4: device manufacture date: unknown, as the involved lot number was not provided.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The manufacturing record and the shipping inspection record of the product with the involved product code found no anomaly in any lot over the past two years.No other similar report from other facilities was found in any lot over the past two years.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record over the past two years.In this case, it was reported that the combined device (guidewire) broke (a wire fragment was left entrapped within the central pa [pulmonary artery] stent struts).However, since the actual device was not returned and investigation of it could not be performed, it was not possible to clarify the causal relationship between the actual device and the breakage of guidewire.Ashitaka factory has been making efforts in maintaining the quality of the product by performing following inspections.After the product assembling process, the outer diameter of catheter is measured on 100% basis to confirm that there is no anomaly in it.After the product assembling process, 100% visual inspection is performed to confirm that there is no anomaly such as a kink or crush.After the product assembling process, a core wire is inserted on 100% basis to confirm that there is no anomaly in the catheter lumen.Terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
Terumo medical received an fda medwatch report number mw (b)(4): "describe the event or problem: a patient went to the catheterization lab for a stent placement procedure.During their procedure, it was determined that the microcatheter tip embolized to the right upper pulmonary artery and a wire fragment was left entrapped within the central pa [pulmonary artery] stent struts.The angulation of the stent in relation to the pulmonary artery and acute angle may have made the catheter more prone to getting stuck on the edges of the stent.The wire got tangled in the large amount of stent material in the pulmonary artery.What was the original intended procedure: stent placement.What problem did the user have: device failed (e.G.Broke, couldn't get it to work or stopped working) relevant pre-existing medical conditions: other characteristics or medical conditions: complex cardiac history." additional information was received on 07ap2025: the medsun report stands alone, no additional information could be shared.

• Brand Name: FINECROSS
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 21890882
• Report Number: 9681834-2025-00071
• Device Sequence Number: 12858808
• Product Code: KRA
• UDI-Device Identifier: 04987350703187
• UDI-Public: (01)04987350703187
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082519
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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 Model Number: 35-1450
• Device Catalogue Number: NC*F865A
• 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: 03/17/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: HI-TORQUE STEELCORE (1007710)
• Patient Age: 10 MO
• Patient Sex: Male
• Patient Weight: 8 KG
• Patient Ethnicity: Hispanic
• Patient Race: White