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

Model Number	CG416
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A4: weight: 97.52kgs.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: bsn, rn, st clinical expert, surgical nursing.The actual sample has been received yet.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.History investigation of the product with the involved product code/lot number - no anomaly was found in the manufacturing record and the shipping inspection record.- no other similar report was found in the past complaint file.(b)(4) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).Please refer to section h10 for the importers report on the reported event.
Event or Problem Description
Terumo medical corporation received the following reported information: during an angiogram with interventions, the glidecath broke off into the patient.The doctor was able to recover the broken piece from the patient.Additional information was received on (b)(6) 2025: the vessels throughout the aortoiliac and femoral-popliteal area were extremely atherosclerotic and diseased.There was a high-grade focal stenosis in the mid right common iliac.The glidecath broke inside the patient during access.The broken piece was recovered.The distal iliac vessels were patent.The common femoral was heavily diseased but patent.The superficial femoral artery (sfa) occluded proximally with dense calcified plaque throughout into the above-knee popliteal.The below-knee popliteal was patent with two-vessel runoff into the foot.Surgeon unable to cross the right superficial femoral artery (sfa) occlusion however, they did get good angiographic result after treatment of the right common iliac with return of a strong right femoral pulse.The estimated blood loss was less than 250cc.Additional information was received on (b)(6) 2025: there was no impact on the patient.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to correct section b4 and to update section h3, and to provide the completed investigation results.Device for investigation actual glidecath (broken off into two portions; referred to as distal, and as proximal).Thereafter, referred to as the distal side and the main part side.Appearance of the actual device it had been fractured at approximately 153mm from the distal end.Since it was fractured at the end of the reinforcement, reinforcement was not found at the distal side, but at the main part side.It had been buckled in the vicinity of the fractured part at the distal side.A trumpet-shaped opening was observed at the fractured part on the distal side and on the main part side.It had been elongated at the fractured part on the distal side and on the main part side.It had been abraded in the vicinity of the fractured part on the distal side and on the main part side.The shape of the fractured part on the distal side and on the main part side matched.Dimensions of the actual device the outer diameter and inner diameter (except the vicinity of the fractured part): they met a factory's specification.No anomaly was found history investigation of the involved product code/lot number no anomaly was found in the manufacturing record and the shipping inspection record.Simulation test from the shape of the fractured part (elongation, trumpet shaped opening), it was considered that excessive tensile load was applied to the actual device, resulting in the fracture.Therefore, as a simulation test, an excessive tensile load was applied with the distal side of the current product trapped.-it was fractured at the end of the reinforcement, and the reinforcement was observed to be exposed in the main part side.The trumpet shaped opening was observed at the fractured part.It was elongated at the fractured part.This condition was considered to be similar to that of the actual device.Cause of occurrence no anomalies were found in the manufacturing record and dimensions.From the investigation results, the following mechanism was considered as one of the possibilities.The actual device was contacted with some object and trapped at approximately 153 mm (the fractured part).It was pushed and pulled with it trapped, causing the involved part to be abraded and buckled.Furthermore, the tensile load was applied, stress was concentrated in the vicinity of the end of the reinforcement which is a physical transition part, and it was fractured.Countermeasure: ashitaka factory assures the quality of this product by performing the following work and controls.After the shaft is molded on the core wire whose outer diameter is controlled, the core wire is removed so that the inner diameter of the shaft is assured.Before the packaging process, 100% magnifying inspection is performed to ensure that there is no anomaly such as fracture on the catheter.In the packaging and cartoning processes, dedicated tools and containers are used for handling this product to protect the product and to prevent the kink.The ifu of this product provides the following information: instruction for use: the radifocus glidecath should be used by a physician who is well trained in manipulation and observation under fluoroscopy.Direction for use.Warning: never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.Failure to exercise proper caution may result in damage to the vessel or catheter.Separation of the catheter may occur requiring retrieval in some cases.Terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: GLIDECATH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuok 418-0 015; JA 418-0015
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuok 418-0 015; JA 418-0015
• Manufacturer Contact: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 23478049
• Report Number: 9681834-2025-00201
• Device Sequence Number: 10526585
• Product Code: DQO
• UDI-Device Identifier: 04987350772213
• UDI-Public: (01)04987350772213(17)271031(10)241129
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K915414
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: CG416
• Device Catalogue Number: RF*ZV94110A
• Device Lot Number: 241129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2024
• 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
• Patient Age: 72 YR
• Patient Sex: Male