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

Model Number	GM1833
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the distal tip of the guidewire (gw) gold broke off while advancing the wire in a calcified stent in the femoral artery.A cook guiding sheath and catheter were used to advance the gold wire into the occlusion located in the lumen of a previously implanted stent.The patient was ok, and the procedure outcome was successful.Additional information was received on 30november2021.The tip was not removed.They are bringing the patient back for a bypass surgery, however, they felt as though the tip was secured in the calcification of the stent.
Additional Manufacturer Narrative
Implanted date - device not implanted.Explanted date - device not explanted.The actual device has 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 of the involved product/lot# combination confirmed there was no problem in them.A search of the complaint file found no other report with the involved product code/lot# combination.Please see mdr (b)(4) for the importer report.(b)(4).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.The actual device was returned to ashitaka for evaluation.Visual inspection of the actual sample found that the distal portion had been broken and missing.Magnifying inspection of the actual sample found that the outer layer near the broken end had been stretched.A convex shape was observed in the stretched part of outer layer, which was considered the tip of the core wire.Electron microscopic inspection of the actual sample found that the outer layer on the broken end seemed to have been torn off, multiple creases were found on the outer layer near the broken end, and multiple cracks and rough surface were observed on the convex-shaped area.The outer diameter of the actual sample was measured and confirmed to be within the control standard.The core wire of the actual sample was found to measure 2981 mm in length.As the normal length of this product code is 3000 mm, it was considered that the distal portion of 19 mm in length was missing from the actual sample.The core wire of the actual sample was separated from the outer layer and then inspected under an electron microscope.The broken end was not tapered, and dimple pattern was observed on the broken surface.Mechanism of breakage of the guidewire: it is known from our past experiments that the guidewire may get broken off when it has been subjected to one of the loads described below.In addition, the state of the broken ends of the core wire presents some regularity depending on the mechanism of the breakage.Repeated bending load at a 90-degree angle.The broken ends are not deformed in a tapered shape and dimple pattern is observed on the broken surface.This state is similar to that of the actual sample.Continuous one-way torque load to a bent wire.The broken ends are not deformed in a tapered shape and radial pattern is observed on the broken surface.The mechanism of breakage is thought to be different from that of the actual sample.One-way pulling load.The broken ends become tapered in diameter.The mechanism of breakage is thought to be different from that of the actual sample.Pulling load to a loop-shaped wire.The broken ends become curved and tapered.The mechanism of breakage is thought to be different from that of the actual sample.Based on the results of the investigation and knowledge from the past simulation test, it is presumed that the actual sample broke due to metal fatigue caused by an excessive and repeated bending load applied to it.After that, it was thought that the outer layer was torn off and separated by the tensile load during removal.The missing length was thought to be about 19 mm.Ashitaka factory assures the quality of this product by implementing the following work and inspections.Eddy current flaw detection is performed at our supplier to assure the integrity of the core wire for this product.The outside diameter of the core wire is strictly controlled to assure the strength of the core wire.100% visual inspection is performed before the packing process.Ifu states: "if any resistance is felt or if the tip's behavior and/or location seem improper, stop manipulating the glidewire and/or the catheter and determine the cause by fluoroscopy.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
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: mary o'neill ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13095696
• Report Number: 9681834-2021-00240
• Device Sequence Number: 4193306
• Product Code: DQX
• UDI-Device Identifier: 04987350712165
• UDI-Public: 04987350712165
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K863138
• 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
• Report Date (Section B): 12/28/2021

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: 10/31/2022
• Device Model Number: GM1833
• Device Catalogue Number: GM1833
• Device Lot Number: 201117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2020
• 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: 180CM .018 GT WIRE.; COOK CATHETER.; COOK GUIDING SHEATH.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown