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	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight - requested, not provided.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.For this reason, investigation conclusions code 11 has been referenced.A review of the device history record and the shipping inspection record of the involved product code/lot# combination was conducted with no findings.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
During a right leg thrombectomy procedure it was reported that the tip of the glidewire advantage broke off in the penumbra cat 6 catheter.The cat 6 catheter became stuck in the artery and the patient had to have surgery to have it removed.A cut down was preformed to remove penumbra catheter.The patient was stable.The procedure was completed.Additional information was received on 02jul2021.Per the catheter rep who is in the procedure at the time, and he did not think the wire malfunctioned at all, he thought when they were taking the catheter out the physician, when cutting the catheter out, cut the tip the wire.Additional information was received on 06jul2021.The patient's condition was reported to be fine, and no part was left in the patent's body.
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.The actual sample was received for evaluation.Visual revealed that the distal end of it had been fractured.Then, the actual sample was compared with the current product.Compared to the current product with a total length of approximately 2600mm, the actual sample was approximately 2545mm (base side), and a shortage of approximately 55mm was observed.Magnifying inspection of the side of fractured section and the opposite side found that the outer layer had been fractured.Electron microscopic inspection of the side surface of fractured section revealed: torn shapes were observed at the fractured section of outer layer; wrinkles on the outer layer were observed; an elongation on the outer layer was observed.Electron microscopic inspection of the opposite side surface of fractured section revealed: wrinkles on the outer layer were observed; an elongation on the outer layer was observed.The outer layer of actual sample was removed, and electron microscopic inspection of the appearance of wire was performed and revealed: a curve was observed on the side surface of fractured section of the wire; there was no tapering on the side surface of fractured section of the wire; a dimple pattern (a hole-shaped pattern) was observed on the fracture surface of wire; the outer diameter of actual sample in the vicinity of fractured section was measured and confirmed to meet the specifications.Simulation tests performed in the past: there is regularity in the shape of fractured section of the wire depending on the mechanism leading to the fracture.Apply repeated bending force: 90 ° bending force was repeatedly applied until fracture occurred.There was no tapering on the side surface of fractured section of the wire, and a dimple pattern (a hole-shaped pattern) was observed on the fractured surface of wire.From this result, it was likely to be similar to the state of actual sample.Apply pulling force in a looped state: pulling force was applied in the looped state until fracture occurred.The side surface of fractured section of the wire was tapered and curved, and a dimple pattern was observed on the fractured surface of wire.The dimple pattern of actual sample was seen on the entire fractured surface, however, the pattern here was only a part of the surface.From this result, it was likely that the mechanism of occurrence was different from that of the actual sample.Apply continuous torque force in one direction with the guidewire curved.Apply continuous torque force in the same direction until fracture occurred.The side surface of fractured section of the wire was flat with no taper, and a radial pattern was observed on the fractured surface of wire.From this result, it was likely that the mechanism of occurrence was different from that of the actual sample.Apply pulling force.Pulling force was applied until fracture occurred.The side surface of fractured section of the wire was tapered.From this result, it was likely that the mechanism of occurrence was different from that of 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.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 was likely that when the actual sample passed through the occluded part, bending force was repeatedly applied, causing the wire to bend and fracture due to metal fatigue.After that, the outer layer was elongated, torn, and separated due to the force at the time of removal.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• 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
• MDR Report Key: 12238185
• Report Number: 9681834-2021-00135
• Device Sequence Number: 14726871
• Product Code: DQX
• UDI-Device Identifier: 04987350703644
• UDI-Public: 04987350703644
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: GA3502
• Device Lot Number: 210319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 09/22/2021
• 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: PENUMBRA CAT 6 CATHETER
• Patient Age: 70 YR