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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: 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, evaluation code 11 has been referenced in the conclusions section of h6.A review of the device history record and the shipping inspection record of the involved product/lot# combination confirmed that there were no findings.A search of the complaint record did not find any other report with the involved product/lot# combination.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.- attachment: [uf medwatch 0600010000-2018-8003.Pdf].
Event or Problem Description
The user facility reported per medwatch (b)(4) while snaring a wire, a piece of the wire broke off in the patient.This was noted after the stents were placed.The wire can be seen on fluoroscopy and it is believed to be between two stents.The surgeon believes it is better to not remove the wire, it will not migrate.Due to the length of the procedure, the doctor stated it is better to leave it in and maybe come back at a later date to perform an ivus on the patient.The original procedure was a stent placement.An x-ray was obtained for the record.Per medwatch additional information: the guidewire was left in place as it was lodged between two grafts.
Additional Manufacturer Narrative
Reproductive test was performed on a product sample: repetitive bending forces at a 90-degree angle till it was fractured.Subsequent electron microscopic inspection of the fracture revealed that the fracture cross section had a dimple pattern with no diminishment of the outside diameter toward the fracture end.A product sample was subjected to repetitive one-way torque forces till it was fractured.Subsequent electron microscopic inspection of the fracture revealed the generation of a radial pattern on the fracture cross-section surface.A product sample was subjected to a one-way pulling force till it was fractured.Subsequent electron microscopic inspection of the fracture revealed the outside diameter of the wire had been diminished toward the fracture end.A product sample was subjected to a pulling force in the state of being formed into a loop-like shape till it was fractured.Subsequent electron microscopic inspection of the fracture revealed the edge of the fracture was in the curved shape.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." it is likely that the actual sample was exposed to force.With no device return 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 april 19, 2018.Estimated blood loss, was 500 ml.The patient condition was reported to be stable.The wire broke off while using the snare, and the piece of the wire was still located in the patient.

• Brand Name: RADIFOCUS GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 7450525
• Report Number: 9681834-2018-00054
• Device Sequence Number: 113288
• Product Code: DQX
• UDI-Device Identifier: 04987350773630
• UDI-Public: 04987350773630
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2018

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: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: GS3508
• Device Lot Number: 171211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 05/14/2018
• 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: STENT; STENT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR