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

Catalog Number	RG*GW1618FM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k) - k955801, k170417.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.A review of the device history record and the shipping inspection record of the involved product code/lot# combination was conducted with no findings.(b)(4).
Event or Problem Description
The user facility reported that the involved glidewire gt was used during the procedure.Advanced practice radiographer.The doctor had an issue with the gt wire snapping.The doctor stated he was a performing a pae and was using the gt wire to navigate into tortuous prostate arteries.The case was challenging and prolonged (two hours) and he used the gt wire on both sides.While manipulating the tip broke off within the obturator artery.He was able to remove the wire tip intact by withdrawing the direction microcatheter with aspiration.The patient was unaffected, and it caused minimal delay, they just had to re-insert microcatheter and wire.The patient was not harmed.The procedure was completed successfully.Additional information was received on 09nov2020.The entire guidewire was removed by withdrawing the whole direction catheter while applying suction.The procedure was completed; however, access had to be re-gained with new devices.
Additional Manufacturer Narrative
The actual sample was received for evaluation.Visual inspection revealed that the actual sample had been broken at approximately 225 mm from the distal end and separated in two portions.The total length of the two portions was confirmed to be 1800 mm, which indicated that there was no missing portion in the actual sample.Distal portion: approximately 225 mm in length; proximal portion: approximately 1575 mm in length.Magnifying and electron microscopic inspections of both broken ends revealed that the urethane coat had been twisted and torn.Electron microscopic inspections of the core wire removed from the urethane coat revealed some radial streaks on the broken surface of both portions.The outer diameter of the actual sample was measured on a part other than the broken ends and confirmed to meet the factory's control criteria.No anomaly in the outer diameter was observed.Mechanism of breakage of guidewires: it is known that the guide wire may become broken off when it has been subjected to one of the following loads.In addition, as for the core wire, the state of the broken ends presents some regularity depending on the mechanism of breakage.One-way pulling load: the outside diameter of the wire has been diminished toward the broken ends.This state is different from that observed in the actual sample.Repetitive bending load at a 90-degree angle: the broken ends are not deformed in a tapered shape.Dimple pattern is observed on the fracture surface.This state is different from that observed in the actual sample.Continuous one-way torque load: the broken ends are not deformed in a tapered shape.Radial streaks are observed on the broken surface.This state is similar to that observed in the actual sample.Pulling load to a test sample kept in a loop shape: the broken ends have been curved.This state is different from that observed in the actual sample.Ifu states: if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the guide wire gt and/or the catheter and determine the cause by fluoroscopy.Continuing to manipulate or rotate the guide wire gt 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.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the core wire was broken off due to the actual sample having been subjected to a continuous one-way torque load, and then the urethane coat was twisted and torn off because the torque load had continued to exert on the actual sample.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: RADIFOCUS GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10866918
• Report Number: 9681834-2020-00234
• Device Sequence Number: 3769056
• Product Code: DQX
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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: 04/30/2022
• Device Catalogue Number: RG*GW1618FM
• Device Lot Number: 200515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DIRECTION CATHETER; DIRECTION CATHETER
• Outcome Attributed to Adverse Event: Required Intervention