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

Model Number	CG412
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: lead cardiac cath tech.The actual sample has been received yet.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.The manufacturing record and the shipping inspection record of the product with the involved product code/lot number was investigated.No anomaly was found.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 4fr glidecath was placed up and over the aortic bifurcation contralaterally from the left side.While pulling the catheter back across the bifurcation the catheter tore with approximately 30% of the catheter lodging itself in the right common iliac.The right groin was accessed, and the broken piece of catheter was snared and safely removed.The physician stated that the patients' vessels were calcified.The were no blood loss.The patient condition was stable.The procedure was an aorta bilateral femoral angiogram.Additional information was received on 18apr2025: the doctor believed the patients calcification had something to do with the issue.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9 and section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.The actual device was received.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 approximately 155mm from the distal end.- the fractured piece had been trapped with a snare.- the shape of fractured piece had been matched that of main body.- the reinforcement had been exposed at the fractured section of main body.- it had been fractured at the end of reinforcement, and no reinforcement was found in the fractured piece side.- 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 in the vicinity of fractured section and at approximately 30mm from the fractured section (at approximately 125mm from the distal end).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.- no anomaly such as an abrasion was found 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.Udi no.(b)(4).Simulation test based on the condition of actual device (fractured piece had been abraded, and the fractured section had been elongated and had been opened in the shape of a trumpet), it was likely that when some hard object came into contact with the distal side of actual device (fractured piece side), excessive pulling force was applied, causing it to fracture.Therefore, as a simulation test, excessive pulling force was applied when the distal side of current product was trapped.[test result] - it was found that the end of reinforcement was fractured, and the reinforcement was exposed at the main body.- 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.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 approximately 155mm from the distal end (the fractured section) or at approximately 125mm from the distal end of actual device was abraded at the calcified lesion and was trapped.- as the actual device was pushed and pulled while trapped, the involved section was abraded and 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.The ifu of this product includes the following instruction for use and warning.- 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.(b)(4) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• 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: 22023932
• Report Number: 9681834-2025-00063
• Device Sequence Number: 15270493
• Product Code: DQO
• UDI-Device Identifier: 04987350772138
• UDI-Public: (01)04987350772138(17)250831(10)220915
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/14/2025

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 Expiration Date: 08/31/2025
• Device Model Number: CG412
• Device Catalogue Number: RF*ZM7410GA
• Device Lot Number: 220915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• 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 Sex: Unknown