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	02/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: 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.E3: occupation: practice manager.The actual sample has not 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.Terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Please refer to section h10 for the importers report on the reported event.
Event or Problem Description
The user facility reported that the doctor was doing a leg intervention and was trying to get up and over with a long 5fr x 45cm sheath.The bifurcation was very steep, so he advanced a amplatz wire over and took dilator out.He put the cg416 in and tried to advance down the contralateral side.There was a lot of calcifications on the contra iliac side and when he pulled the glidecath back it broke off in the patient.He snared the piece and there were no complications.The patient was stable.There was no blood loss.Additional information was received on 05mar2025: testing was performed to verify the piece was removed entirely.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9, section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.Investigated device - actual glidecath (it had been fractured into two pieces: distal side [fractured piece] and hub side [main body]) appearance confirmation of the actual device - it had been fractured at approx.160mm from the distal end.- the shape of fractured piece had been matched that of main body.- the reinforcement had been exposed at the fractured section of main body.- there was no reinforcement inside fractured piece, and the reinforcement had been fractured at its end.- no anomaly such as jumbling of the reinforcement was found inside main body (other than the exposed section).Appearance confirmation of fractured piece - the fractured section had been opened in the shape of a trumpet.- there was an elongated part at the fractured section.- it had been buckled in the vicinity of fractured section.- it had been abraded, and the surface had been roughened in the vicinity of fractured section.Appearance confirmation of main body - the fractured section had been opened in the shape of a trumpet.- there was an elongated part at the fractured section.- it had been abraded, and the surface had been roughened in the vicinity of fractured section.Confirmation of dimensions of the actual device - outer and inner diameters of the actual device (other than the vicinity of fractured section): they met the factory's specifications.No anomaly was found.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.Udi no.(b)(4).Simulation test based on the condition of actual device (fractured piece and main body had been abraded and elongated, and the surface had been roughened), it was likely that when some hard object came into contact with the surface of actual device, excessive pulling force was applied, causing it to fracture.Therefore, following simulation test was performed assuming that excessive pulling force was applied when the device came into contact with a calcified lesion and was trapped.[test result] - it was found that the reinforcement was exposed at the fractured section.- it was found that the fractured section was opened in the shape of a trumpet.- it was found that there was an elongated part at the fractured section.- it was found that it was abraded, and the surface was roughened in the vicinity of fractured section.These conditions were likely to be similar to those of the actual device.(cause of occurrence) no anomaly was found in the manufacturing record and the dimensions of actual device.Based on the investigation result and the issue described in the ppr, as a possible cause of this case, the following mechanism was inferred.However, since the details of procedure were unknown, it was not possible to identify the cause of occurrence.- the section at approx.160mm from the distal end of actual device (the fractured section) was trapped in the calcified lesion.- as the actual device was pushed and pulled while trapped, the involved section was abraded, the surface of it was rough, and it was buckled.- as further pulling force was applied, stress was concentrated near the end of reinforcement, which is the transition area of physical properties, and the reinforcement fractured.(countermeasure) ashitaka factory assures the quality of this product by performing following work and controls.- after the shaft is molded around the core wire of which the outer diameter is strictly controlled, the core wire is removed to assure the inner diameter of shaft.- before the packaging process, 100% magnifying inspection is performed to confirm that there is no anomaly such as a 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 occurrence of the kink.Instruction for use and warning.: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, 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: 21692847
• Report Number: 9681834-2025-00040
• Device Sequence Number: 15761500
• Product Code: DQO
• UDI-Device Identifier: 04987350772213
• UDI-Public: (01)04987350772213(17)270228(10)240311
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: 240311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 5FR X 45CM SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female