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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/04/2024

Event Type  Injury  

Event Description

The user facility reported that the tip of the involve glidewire wire broke off in the patient during a procedure.They were able to retrieve the tip of the wire with a snare, and nothing was left inside the patient.There was no harm to the patient.The reported event did not result in patient injury or require surgical intervention.There is not a direct allegation that the reported device caused or contributed to patient injury.The event occurred intra-operative.Additional information was received on 07 mar 2024: the procedure performed was a thrombectomy with inari equipment.The patient's anatomy was tortuous when working with the wire that broke.The size of wire tip that broke off was 3 centimeters (cm).They were using an inari's thrombectomy device with the guidewire at the time of breakage.

Manufacturer Narrative

D6a: implanted date: device was not implanted; d6b: explanted date: device was not explanted; e3: occupation: purchasing.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.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past complaint file.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
• Type of Device: 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: 18987106
• MDR Text Key: 338718063
• Report Number: 9681834-2024-00047
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04987350703644
• UDI-Public: 04987350703644
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• 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: GA3502
• Device Lot Number: 230914
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2023
• 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
• Treatment: INARI'S THROMBETOMY DEVICE.
• Patient Outcome(s): Required Intervention; Other