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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the tip of an endovascular "glidecath" was noted to be missing after it was removed from the patient.The surgeon did not believe there was any patient harm, the patient was fine.There was no blood loss.The reported event did not result in patient injury and/or require medical or surgical intervention.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.Additional information was received on 06may2024: no reported adverse patient effect due to the incident.The procedure was successful.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided due to hospital policy.A2: age & date of birth: requested, not provided due to hospital policy.A3a: sex: requested, not provided due to hospital policy.A3b: gender: requested, not provided due to hospital policy.A4: weight: requested, not provided due to hospital policy.A5: ethnicity: not provided for animal use.A6: race: not provided for animal use.D4: lot number: requested, unknown.D4: expiration date: unknown due to unknown lot number.D6a: implanted date: device was not implanted due to hospital policy.D6b: explanted date: device was not explanted due to hospital policy.E2: health professional: unknown.E3: occupation: vascular or nurse clinician.Since the actual sample was not returned, investigation of it could not be performed.Since the involved lot was unknown, it was not possible to investigate the manufacturing records, the shipping inspection records and the past complaint files.Regarding all the product types of glidecath, there have been no cases of fracture due to manufacturing defects over the past three years.No cases of fracture due to manufacturing defects have been confirmed for any product types of glidecath over the past three years.In this case, it was inferred possible that the fracture occurred due to an excessive tensile force having been applied to the actual sample for some reason.However, since the actual sample was not returned and analysis of it could not be performed, it was not possible to clarify the cause of occurrence.(b)(6) 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 shaft is assured.Before the packaging process, 100% magnifying inspection is performed to confirm that there is no anomaly such as a deformation on the catheter.In the packaging and cartoning processes, dedicated tools and containers are used for handling this product to protect it and to prevent it from deforming.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 2243441-2024-00011.

• Brand Name: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH.
• Common Device Name: 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: 19277666
• Report Number: 9681834-2024-00075
• Device Sequence Number: 7592789
• Product Code: DQO
• UDI-Device Identifier: 04987350772190
• UDI-Public: 04987350772190
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K915414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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: N/A
• Device Catalogue Number: CG415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/09/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown