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

Model Number	N/A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the physician was performing standard angioplasty over the.014 guidewire advantage (gwa) and the wire started to peel apart almost and disintegrate.The patient had no issues.Additional information was received on 10 july 2022: none of the wire was left in the patient.The procedure was completed successfully.No medical/surgical intervention was required.The patient was stable.Another.014 wire was used to complete the procedure.
Additional Manufacturer Narrative
Patient identifier: requested, not provided.Age and date of birth: requested, not provided.Patient sex: requested, not provided.Weight: requested, not provided.Ethnicity: requested, not provided.Race: requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: ir lead.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 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.(b)(4).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, to update section h3 and to provide the completed investigation.The actual sample was received by ashitaka factory on august 10, 2022.Visual inspection of the actual sample upon receipt obtained following results: · it had been scratched at approx.155mm - 245mm from the distal end.· the ptfe coat had been peeled off and the wire had been exposed at approx.280mm - 610mm from the distal end.Magnifying inspection of the scratched section found that the wire had been exposed intermittently.Magnifying inspection of the peeled section on the ptfe coat found that the outer layer had been peeled off over half the circumference.Electron microscopic inspection of the scratched section found that the edge of scratch was arc-shape.Electron microscopic inspection of the peeled section on the ptfe coat found the scratch with streak patterns on the wire.The outer diameter of actual sample was measured and confirmed to meet the specifications.The total length of actual sample was measured and confirmed to meet the specifications.A search of the complaint file found no other similar report with the involved product code/lot# combination from other facilities.Based on the condition of actual sample, it was presumed that the removal operation was performed while some hard object was in contact with the outer layer of guidewire, which caused the ptfe coating to peel off and the urethane coating to be damaged.Therefore, the simulation test was performed assuming that the metal needle of the device which was used together came into contact with the involved product when the guidewire was removed.Magnifying inspection of the simulated product obtained following results: · the urethane coat was scratched intermittently and the wire was exposed.· the outer layer was peeled off and the wire was exposed on the ptfe coat.Electron microscopic inspection of the simulated product obtained following results: · the edge of scratch was arc-shape.· the scratch with streak patterns was found on the wire.The condition of simulated product was likely to be similar to the actual sample.However, the peeling of outer layer of the ptfe coating was larger in the actual sample.This difference was inferred to be affected by the difference in the metal needles used together and the operation method.It was presumed that since the removal operation was performed while some hard object was in contact with the actual sample, the outer layer was peeled off, the wire was exposed, and the urethane coating was scratched on the ptfe coat.From the simulation test result, it is possible that this event may occur when the withdrawal operation of guidewire is performed while the metal needle is being used.Ashitaka factory manufacturing process assures the quality of this product by performing 100% visual inspection to confirm that the wire is not exposed and there is no anomaly in the appearance.Relevant ifu reference: "do not manipulate or withdraw the glidewire advantage through a metal entry needle or a metal dilator.Manipulation and/or withdrawal through a metal entry needle or a metal dilator may result in destruction and/or separation of the outer polyurethane coating requiring retrieval.A plastic entry needle is recommended when using this wire for initial placement." 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: 15127279
• Report Number: 9681834-2022-00147
• Device Sequence Number: 5447029
• Product Code: DQX
• UDI-Device Identifier: 04987350717924
• UDI-Public: 04987350717924
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: GA1430
• Device Lot Number: 211125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2021
• 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