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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation: cath lab manager.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 history record and the shipping inspection record of the involved product code/lot# combination confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot# combination from other facilities.Terumo medical products (tmp) (importer) registration no: (b)(4) is submitting this report on behalf of ashitaka factory of (b)(4) corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The user facility reported that the tip of the glidewire fractured in the case.The patient was stable, and the procedure was a success.There were no other devices or equipment used with the reported product.Additional information was received on 26 aug 2022: the tip of the wire was frayed when removed from the patient.The procedure performed was a diagnostic peripheral.There were no pieces left behind or that fell into the patient.Additional information was received on 30 aug 2022: the physician stated that the wire's most proximal end showed signs of flaking or crumbling, however when the terumo territory manager looked at the device, and he didn't see any signs of it breaking.
Additional Manufacturer Narrative
The actual sample was received by ashitaka factory on october 31, 2022.Visual inspection of the returned actual sample found peeling of outer layer at four locations (at approximately1455 mm, 1465 mm, 1495 mm, and 1520 mm from the distal end).Magnifying inspection of the outer-layer peeled sites of the actual sample obtained the following results.All the fractured ends of the outer layer were shaped like torn-off.A scratch was observed at a point where the core wire was exposed.All the fractured ends of the outer layer were twisted.Magnifying inspection of other points found no external anomalies such as scratches.Electron microscopic inspection found a rip and creases in the vicinity of the outer- layer peeled sites.From the investigation 2 and 4, since all the four outer-layer peeled sites had similar characteristics, it was inferred that they had occurred by the same mechanism.The outer diameter of the normal part of the actual sample was measured and found to be within the control standard, and no anomaly was observed.Simulation test: from the condition of the actual sample, it was inferred that external force had been applied to the actual sample while some hard object was in contact with the sites in question.Based on this, simulation tests were implemented where a test sample was subjected to torque force and push-pull force while a torque device was attached to the test sample.Both metal and plastic torque devices were used.Combination with metal torque devices visual inspection of the tested sample found peeling of outer layer and exposure of core wire.Magnifying inspection of the outer-layer peeled sites of the actual sample obtained the following results.Torn-like shape was observed.A scratch was observed at a point where the core wire was exposed.Twisting of the outer layer was observed.Electron microscopic inspection of the tested sample found creases in the vicinity of the outer-layer peeled site.From the above investigation result, the sample tested with a metal torque device was considered similar to the actual sample.However, it was observed that the torn-off shape of the tested sample was larger than that of the actual sample.This difference was thought to be due to the degree of adhesion between the outer layer and the torque device and the influence of manipulation.Combination with plastic torque device visual inspection of the tested sample found no peeling of outer layer (page 10).Magnifying inspection of the tested sample found that the outer-layer surface had been roughened.Electron microscopic inspection of the tested sample found roughened outer layer in the diagonal direction.From the above investigation results, it was confirmed that the state of the sample tested with a plastic torque device was different from that of the actual sample, therefore, the mechanism of occurrence was considered different from that of the actual sample.From the results of the investigation, it was inferred that the actual sample was exposed to an external force while some hard object was in contact with it, which resulted in the peeling of outer layer and the exposure of core wire.Based on the results of the simulation tests, the peeling of the outer layer may occur when the actual sample was exposed to toque force and push-pull force while a metal torque device is used concurrently.Ashitaka factory manufacturing process assures the quality of this product by performing 100% visual inspection to confirm there is no exposure of core wire or other anomalies in the appearance.Ifu states: " use the enclosed radifocus torque device to handle the guide wire m.Donot use a metal torque device with the guide wire m.Use of a metal torque device may result in damage to the wire.Do not slip a tightened up torque device or y-connector over the wire, as this may result in damage to the wire." 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 GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
• 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: gina digioia ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15462885
• Report Number: 9681834-2022-00186
• Device Sequence Number: 20548940
• Product Code: DQX
• UDI-Device Identifier: 04987350773654
• UDI-Public: 04987350773654
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: GS3509
• Device Lot Number: 211209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 09/22/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2021
• 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
• Patient Sex: Unknown