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

Model Number	RF*GA35153A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: explanted date: device was not explanted h6: patient code: 3191 no code available - device fragment was in the patient, however, the fragment was removed.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, evaluation code 11 has been referenced in the conclusions section of h6.A review of the device history record and shipping inspection record of the 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.Exemption number e2015022.
Event or Problem Description
The user facility reported that while attempting to do an external iliac intervention the physician had the glidewire up the left side with plan of going to the right side.The distal portion of the glidewire snapped off inside of the patient, with no excessive exertion on the wire.The physician was able to use a snare to remove the broken piece and no injury to the patient was reported.No other devices were being used with the wire at the time.The procedure was completed successfully with a new glidewire.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
The actual sample was received for evaluation.Visual inspection revealed that the actual sample had been fractured off at approximately 80mm from the distal end of the device.The distal end of the fractured section had a kink at approximately 70mm from the distal end of the device.The main body and the fractured distal piece measured as follows: fractured distal piece: approximately 80mm; main body: approximately 1420mm; in total: approximately 1500mm; specified total length of this product code: approximately 1500mm.From this, it is most unlikely that there is some portion separated and missing from the main body.Magnifying and electron microscopic inspections of the kink and the fractures revealed; at the kink on the distal fracture section, some creases had been generated on the urethane outer layer.At the distal fracture; the urethane outer layer at the fracture end had the shape implying that it had been ripped off.Some creases had been generated on the urethane outer layer around the fracture end.At the proximal fracture; the urethane outer layer at the fracture end had the shape implying that it had been ripped off.Some creases had been generated around the fracture end.The outside diameter was measured on the undamaged segment and found to meet manufacturer specifications.The urethane outer layer around the fracture end was dissolved for further inspection of the state of the core wire.Electron microscopic inspection of the core wire found that the dimple pattern had been generated on the surface of the fracture cross-section.The outside diameter of the core wire was confirmed to meet manufacturer specifications.Reproductive testing was performed; the sample was subjected to a pulling force in the state of being formed into a loop shape till it became fractured.Subsequent electron microscopic inspection of the fracture revealed that the distal end of the fracture had been curved and diminished with the surface of the fracture cross-section being in the rough state.This state was found to differ from that of the actual sample.The sample was subjected to repetitive 90-degree bending forces till it got fractured.Subsequent electron microscopic inspection of the fracture revealed that the generation of the dimple pattern on the flat fracture cross-section surface, the state was found to be very similar to that of the actual sample.A product sample was subjected to repetitive one-way torque forces in the state of being curved till it became fractured.Subsequent electron microscopic inspection of the fracture revealed the generation of a radial pattern on the fracture cross-section surface.This state was found to be different from that of the actual sample.The sample was subjected to a horizontal tensile force distal end till it got fractured.Subsequent electron microscopic inspection of the fracture revealed that the shaft had been diminished toward the end.This state was found to be 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 catheter or damage to the vessel.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the actual sample was subjected to repetitive bending force on approximately 80mm from the distal end of the device, where metal fatigue occurred and the core wire became fractured first, and subsequent pulling force ripped off the urethane outer layer.It is likely that the actual sample was also subjected to excessive bending force at approximately 70mm from the distal end of the device and became kinked.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: RADIFOCUS GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 8203257
• Report Number: 9681834-2018-00235
• Device Sequence Number: 1657361
• Product Code: DQX
• UDI-Device Identifier: 04987350773159
• UDI-Public: 04987350773159
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: 09/30/2020
• Device Model Number: RF*GA35153A
• Device Catalogue Number: GR3506
• Device Lot Number: 181019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 02/11/2019
• 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: Required Intervention