MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M; WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the glidewire advantage was being used to cross the superficial femoral artery (sfa) from left antegrade approach.While pushing the wire it snapped around 20 cm from the tip.The patient had 5fr micro puncture access.The wire was inserted through the micro access sheath.The patient was undergoing surgery to remove the wire left in the body.The doctor said that he was pushing and pulling in attempt to cross down bypass graft.Anatomy looked to be normal from the common femoral artery (cfa) to mid superficial femoral artery (sfa).Severe peripheral artery disease (pad) was noticed from mid superficial femoral artery (sfa) to distal bypass graft.Patients pre-procedural condition was peripheral artery disease (pad) diagnosis with occluded bypass graft.Patient injury and/or surgical or medical intervention was required.The doctor had to perform open removal of the broken wire.Relevant tests and lab results were an angiogram on (b)(6) 2023.The type of procedure being performed was a left antegrade approach angiogram with thrombolysis.The estimated blood loss was less than 250cc.Additional information was received on 18aug2023: the patient was stable and foreign body removal surgery went well.Guidewire tip was successfully removed from the patient.An open surgical foreign body removal through was performed.Xray was performed to confirm the tip of the wire was removed from the patient.It was seen on x-ray and the other half of the wire did not hydrophilic piece of the wire.
Additional Manufacturer Narrative
Patient identifier: requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: supervisor.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.Review of the manufacturing record and the shipping inspection record no anomaly was found.Search of the complaint file no other similar report from other facilities was found.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).
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9 and h3 and to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Based on our past knowledge, we have been aware that the guidewire fractures when the following force a) - d) is applied.We have also been aware that there is regularity in the shape of fractured part of the core depending on the mechanism leading to the fracture.A) when a guidewire was exposed to repeated 90° bending force and fractured, no taper was found on the side surface of core wire at the fractured part, and dimple patterns were found on the fracture surface of core wire.B) when a guidewire in a curved state was exposed to continuous one-way torque force and fractured, no taper was found on the side surface of core wire at the fractured part, and radial patterns were found on the fracture surface of core wire.C) when a guide wire was exposed to pulling force and fractured, a taper was found on the side surface of core wire at the fractured part.D) when a guidewire in a looped state was exposed to pulling force and fractured, a taper and a curve were found on the side surface of core wire at the fractured part.(cause of occurrence) as one of the possibilities of this case, it was presumed that the fracture occurred in the actual sample by any of the mechanisms a) - d), however, since the actual sample was not returned and the analysis of it could not be performed, the cause of the occurrence could not be clarified.(countermeasure) ashitaka factory assures the quality of this product by performing following work and inspection.- the outer diameter of this product is controlled.- before the packaging process, 100% visual inspection is performed.Ifu of this product includes the following warning: "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.
Additional Manufacturer Narrative
This report is being sent as follow-up no.2 to correct section d3.

• Brand Name: RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, MD 418 ; JA 418
• 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 ; 6402040886
• MDR Report Key: 17706885
• Report Number: 9681834-2023-00187
• Device Sequence Number: 12560990
• Product Code: DQX
• UDI-Device Identifier: 04987350717924
• UDI-Public: 04987350717924
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2023

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: 01/31/2025
• Device Model Number: N/A
• Device Catalogue Number: GA1430
• Device Lot Number: 230220A
• 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: 08/08/2023
• Supplement Date Received by Manufacturer: 11/08/2023; 02/10/2025
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 12/08/2023; 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2023
• 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: VASCULAR SOLUTION 5FR STIFF MICRO PUNCTURE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 154 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White