MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M; 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	03/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.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 inspection record of the involved product code/lot# combination was conducted with no findings.Please see mdr (b)(4) for the importer report.(b)(4).
Event or Problem Description
The user facility reported that the involved radifocus gw had coating or jacket come off of the product during a procedure.The patient was ok, and the procedure was successful.There was no patient injury, medical/surgical intervention required.Additional information was received on 18mar2021.The type of procedure being performed was a peripheral angiogram.There was no coating/jacket left in the patient's body.The product was used for the entire case.There was no blood loss.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information in section b5, and the device return date in section d9, to update section h3, and to provide the completed investigation results.A correction is being provided to section h6, it was inadvertently initially reported that the patient's race was white; however, the patient demographics were not provided.Therefore, the patient's race is unknown.The actual sample was received for evaluation.Visual inspection with the naked eye revealed that the outer layer had been peeled in the range from 193 mm to 220 mm from the distal end, with resultant exposure of the core wire.Magnifying inspection of the peeled outer layer section revealed that the circumferential half portion of the outer layer had been peeled and the core wire was exposed, the outer layer had been peeled as if had been rolled up starting from approximately 220 mm from the distal end.The edge of the outer layer around this area had been deformed in wavy shape with a trace of having been pulled and torn off.The proximal end was in a round shape.The tip of the outer layer lifted from the core wire was in a round shape and wavy deformation was observed.Electron microscopic inspection of the actual sample revealed that at approximately 193 mm from the distal end, creases were observed on the outer layer and the fracture surface was smooth.At approximately 220 mm from the distal end, creases were observed on the outer layer.The fracture surface of the outer layer was partially rough as if it had been pulled and ripped, and partially smooth.The tip of the outer layer lifted from the core wire showed rough fracture surface as if it had been pulled and ripped, and a smooth fracture surface.The outer diameter was measured on the intact section and no anomaly was noted.It is known from the reproductive test and study that the outer layer may be peeled when a guidewire is used in combination with a metal needle.The characteristics seen in a guidewire with a peeling of outer layer attributable to such use conditions: circumferential half portion of the outer layer is peeled, and core wire is exposed.The fracture surface of the peeled outer layer is smooth.The proximal end of the peeled outer-layer part is in a round shape.Creases are observed on the peeled outer-layer surface.The surface of peeled outer layer was smooth.These characteristics are similar to those 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 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.Do not manipulate or withdraw the glidewire through a metal entry needle, metal dilator or metal devices with sharp or rasping edges.Manipulation and/or withdrawal through a metal device with sharp or rasping edges 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.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Where the smooth fracture surface was confirmed in the peeled outer layer, it is likely that the actual sample was exposed to a sharp object.The rough fracture surface of the peeled outer layer, it is likely that a pulling load worked on that area while the actual sample was manipulated.The additional information stated it was reported that the actual sample was not used in combination with a metal needle.However, the similarity between the state of the actual sample and the reproductive test results suggested that combination use of the actual sample with a metal needle.It was conceivable that the actual sample had no deficient portion in the outer layer because the tip of the lifted outer layer matched with the outer layer of around 220 mm from the distal end in terms of the shape and fracture surface.However, the exact cause of the reported event cannot be definitively determined based on the available information.
Event or Problem Description
Additional information was received on 25mar2021.The procedure was a left peripheral angiogram that was intervened with a stent and balloon.No atherectomy was performed.No metal needle was used while the glidewire was used in the procedure.

• 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
• MDR Report Key: 11573896
• Report Number: 9681834-2021-00040
• Device Sequence Number: 3020810
• Product Code: DQX
• UDI-Device Identifier: 04987350773210
• UDI-Public: 04987350773210
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: GR3509
• Device Lot Number: 200611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other