MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION RADIFOCUS GLIDECATH HYDROPHILIC COATED CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/16/2024

Event Type  Injury  

Event Description

The user facility reported that during a peripheral procedure, the glidecath was over the iliac bifurcation over an amplatz wire.The doctor was removing the glidecath to exchange for a navicross and felt some resistance but could not determine what was causing it.He pulled on the glidecath and it broke apart leaving approximately 15cm in the patient.He was able to pull the wire with the remaining catheter into the destination sheath to remove safely.The case was finished successfully and no harm to the patient.The procedure was a left leg angio.There was no blood loss.

Manufacturer Narrative

D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: interventional radiologist.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.1.Manufacturing record and the shipping inspection record of the actual sample - no anomaly was found.2.Past complaint file of the involved product code/lot number - no other similar report of the product with the involved product code/lot number was found.3.Udi no (b)(4).Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.For the importer report for this reported event please see mdr 2243441-2024-00004.

Manufacturer Narrative

1.Actual sample upon receipt: - actual glidecath sample had been broken off into two portions; the distal portion was called as portion a, and the proximal portion as portion b in this report.- a competitor's guidewire used in conjunction with the actual sample.2.Visual inspection of the actual sample (unaided eye, microscope, x-ray fluoroscopy): - the actual sample was broken at approximately 150 mm from the distal end.- the distal end of portion a was not deformed.- there were arc-shaped indentations at approximately 98 mm and 120 mm from the distal end of portion a.- buckling was found at the broken edge of portion a.The broken edge of portion a was the area where there was no reinforcement inside.- the broken edge of portion b was the end of the area where reinforcement was located inside.The broken edge of portion b was stretched over the entire circumference.The lumen was not narrowed, and no anomaly was found.From this, it was inferred that the actual sample was exposed to tensile load and broken off with the competitor's guidewire inserted inside.3.Dimensions of the actual sample: dimensions (inner and outer diameters) of the area with no fracture or deformation were confirmed to meet the factory's specifications.No anomaly was found 4.Combination test: attempts were made to insert the competitor's guidewire into each portion.- when the guidewire was inserted from the distal end of portion a, it was caught on the part where buckling was found.- when the guidewire was inserted from the hub of portion b, the insertion was confirmed possible.As this indicated that the patency of lumen had been secured except for the buckled area of portion a, it was considered that sticking of the guidewire and the actual sample except for the buckled area could be ruled out from the cause in this case.(cause of occurrence) there were no anomalies in the manufacturing record and dimensions of the actual sample.From the condition of the actual sample, the following possibility was considered; however, the cause could not be determined.The actual sample was subjected to some compressive load from side, which resulted in the indentations on the side and in the resistance during removal.As the actual sample in that state was subjected to tensile load, it was broken off at the end of the reinforced area, which is the area where the physical properties transitions.Regarding the buckling of portion a, it was thought to have occurred when portion a was retrieved from the patient after the breakage; however, as the details at the time of usage were unknown, the cause could not be clarified.(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 to assure the inner diameter of the shaft.- before the packaging, 100% magnifying inspection is performed to confirm that there is no anomaly such as a kink or a tear 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 a kink or a tear.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 5.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 products (tmp) (importer) registration no.(b)(4).Is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• Brand Name: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 18947310
• MDR Text Key: 338183867
• Report Number: 9681834-2024-00035
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350772190
• UDI-Public: 04987350772190
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CG415
• Device Lot Number: 230522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White