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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: registered technologist (rt).A review of the manufacturing record and the shipping inspection record of the involved product/lot number combination confirmed there was no problem in them.A search of the complaint file found no other report with the involved product code/lot number combination from other facilities.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.
Event or Problem Description
The user facility reported that the casing of the wire involved sheared from the middle.The issue was noticed outside of the patient and before the product was used.A tip came off the back end of the wire.The product was not used on the patient.The patient was unaffected.The procedure outcome was successful.There was no patient injury/medical or surgical intervention required.Additional information was received on 24 feb 2022: the wire did not have any contact with other equipment.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.H6: investigation findings - code 3211 is based upon the evaluation of user facility information and the returned sample; code 114 is based upon testing of the returned sample.Visual inspection of the actual samples obtained the following results.I) the actual samples were the guidewire (referred to as the main body) and two black fragments (fragment 1 and fragment 2).Ii) exposure of the core wire was observed on the main body where approximately 1008 - 1022 millimeters from the distal end.Iii) fragment 1 and fragment 2 were confirmed to measure approximately 10 millimeters and 8 millimeters respectively.Magnifying inspection of the main body obtained the following results.I) the edge of the outer layer had been elongated at approximately 1008 millimeters and 1022 millimeters from the distal end.Ii) a streak mark was observed on the exposed core wire.Iii) a contact mark was observed at approximately 1040 millimeters from the distal end, and multiple abrasions were observed in the lengthwise direction on the proximal side of the exposed core wire.Iv) the surface of the main body was found glossy.Electron microscopic inspection obtained the following results.I) multiple creases and torn shape were observed on the edges of the outer layer at approximately 1008 millimeters and 1022 millimeters from the distal end.Ii) a dent was observed on the outer layer at approximately 1040 millimeters from the distal end and multiple creases were observed near the dent.Iii) the abrasions were found to have occurred toward the proximal end.Iv) the surface was smooth and crack pattern peculiar to the hydrophilic coating was observed.The outer diameter of the main body was measured at the normal section and confirmed to meet the control standards.Magnifying inspection obtained the following results: i) both edges of both fragments had been elongated.Ii) both fragments were in tube shape and no break was observed in the lengthwise direction.Iii) the middle part of fragment 1 had been deformed.Iv) the outer surfaces of both fragments were non-glossy.Electron microscopic inspection obtained the following results: i) both edges of both fragments seemed to have been pulled and torn.Iii) no scratches were observed on the deformed part of fragment 1.Iv) the outer surfaces of both fragments were rough.V) for both fragments, the surface condition was different between the outer and inner surfaces.Both fragments were cut lengthwise to inspect the inner surface.Electron microscopic inspection of both fragment obtained the following results: i) the inner surface of both fragments were found smooth with a crack pattern on it, which was similar to the outer surface of the guidewire.Ii) multiple creases were observed near the edges of the fragments.Iii) the deformity on fragment 1 was confirmed to be some dents that had occurred from the inner to the outer side.This was like the area approximately 1040 millimeters from the distal end of the main body.Both fragments were subjected to the component analysis by ft-ir and found to have the same ir-spectrum as the outer layer of the guidewire.From this, it was inferred that fragment 1 and 2 were the outer layer that had peeled from the guidewire.Based on the investigation results results on the fragments cut lengthwise to inspect the inner surface and the ft-ir analysis, fragments 1 and 2, fragment 1 and 2 were those peeled from the actual sample and turned inside out.Based on the condition of the actual samples with some dents and lengthwise abrasions on the surface, it was presumed that some hard object may have been put against the guidewire with force and moved over the surface.From our past findings, it is known that the outer layer of the guidewire may be torn off and turned up when excessive torque and push/pull operations are performed with the torque device tightened.From the simulation test results, it was presumed that the outer layer might have been flawed and turned up due to excessive manipulation with the torque device in strong contact.Afterward, when the torque device was detached, the turned up outer layer was torn and separated from the main body.Ashitaka factory is committed to assure the quality of this product by implementing thorough work and inspections, including the followings.I) 100% visual inspection is performed to confirm that there is no turned up part in the outer layer.Ii) the guidewire goes through the dedicated inspection jigs to confirm that there is no turned up part in the outer layer.The following caution is indicated in the ifu of this product: "do not slip a tightened-up torque device over the wire, as this may result in damage to the wire." 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).

• Brand Name: RADIFOCUS GLIDEWIRE ADVANTAGE
• 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: stephanie handy ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 13769389
• Report Number: 9681834-2022-00035
• Device Sequence Number: 11769508
• Product Code: DQX
• UDI-Device Identifier: 04987350773654
• UDI-Public: 04987350773654
• 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): 03/15/2022

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: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: GS3509
• Device Lot Number: 210720
• 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: 02/22/2022
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2021
• 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