MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION RADIFOCUS GLIDEWIRE ADVANTAGE; WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a cerebral angiogram the tip of the guidewire advantage broke off and was inside the catheter.Then, was flushed out into the vessel.The wire was still in the vessel.There was no blood loss.The event occurred intra-operative.Additional information was received on 20 mar 2024: there was difficulty pushing the wire inside of the catheter, to the point of it not easily advancing, then the wire was pulled out and placed on the back scrub table.It was measured that 4mm of the nitinol tip was broken off.There was no interventional plan to go and remove the tip off the wire.The patient was as stable for their status as a post ruptured aneurysm.The patient has a history of meth usage, patient experienced a ruptured aneurysm and had a craniotomy.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: cath lab manager.The actual device was not available; therefore, the actual device will not be returned for evaluation.No anomaly was found in the manufacturing record and shipping inspection record.No other similar event reported from other facilities was found in the past complaint file.According to the investigation results, no anomaly was found in the manufacturing records and shipping inspection records.However, since the actual sample was not returned and analysis of it could not be performed, the cause of occurrence could not be clarified.Ashitaka factory is always making efforts to maintain the product quality through the following work and inspections.The outer diameter of this product is controlled.Before the packaging process, 100% visual inspection is performed to confirm that there is no deformation including a kink or bend.The instructions for use (ifu) of this product indicates as follows: "if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire advantage and/or the catheter and determine the cause by fluoroscopy.Continuing to manipulate or rotate the glidewire advantage or failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter, or damage to the vessel." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: RADIFOCUS GLIDEWIRE ADVANTAGE
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 19042210
• Report Number: 9681834-2024-00049
• Device Sequence Number: 12903053
• Product Code: DQX
• UDI-Device Identifier: 04987350703644
• UDI-Public: 04987350703644
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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 Expiration Date: 05/31/2026
• Device Model Number: N/A
• Device Catalogue Number: GA3502
• Device Lot Number: 230623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2023
• 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: GLIDEWIRE ADVANTAGE 035 260CM.; SIMMONS CATHETER.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Hispanic