MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GUIDEWIRE

Model Number	GR3508
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device was returned to the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, evaluation code 20 has been referenced in the conclusions section of h6.The production lot number was not provided by the user facility which prevented a meaningful review of production and complaint records.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.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Event or Problem Description
The user facility reported coating on the wire had come off during a procedure.Follow up communication with the user facility confirmed the following information: the doctor placing the guidewire for port placement noticed the coating on the wire had come off when the procedure was first started; another wire was used to complete the case; black coating was noticed on the patient's skin; a vascular surgeon was consulted and additional x-rays were taken where it appeared a piece of black coating was in the vessel and sub-q area; and, the patient was reported as doing fine, this was an outpatient procedure and the patient was discharged.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the returned sample evaluation results.(b)(4).The actual device was returned to the manufacturing facility.The sheared and separated portion of the urethane outer layer was not returned for evaluation.Visual inspection upon receipt revealed that the urethane outer layer had been sheared off the core wire on the segment approximately 50mm -290mm from the distal end of the device.Magnifying inspection of the urethane-sheared segment obtained the following.On approximately 50mm - 80mm from the distal device, the urethane outer layer had been sheared off partially with no exposure of the core wire.On approximately 80mm - 290mm from the distal end of the device, the urethane outer layer had been sheared off semi-circumferentially, where the core wire was exposed.The shear cross-section of the urethane outer layer had a smooth surface.The outer diameter of the shaft was measured on the undamaged segment and confirmed to meet manufacturer specifications.Functional testing was conducted.A guide wire sample was inserted and withdrawn through a metal needle.As the result, the urethane outer layer was sheared off semi-circumferentially with the shear cross-section presenting the smooth state.The state of the fracture was observed to be very similar to that of the actual sample.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause of the reported event cannot be definitively determined based on the investigation, it is likely that the actual sample was pulled and pulled through a metal needle in the state of having contact with the edge of a metal device, such as a metal needle.The device labeling does address the potential for such an event in the instructions-for- use (ifu) with statements such as the following: "do not use the glide wire with devices which contain metal parts such as atherectomy catheters, laser catheter, or metal introduction devices as they may cause the glidewire plastic coating to shear and/or sever the wire.Do not manipulate or withdraw the glidewire through a metal entry needle or a metal dilator.Manipulation and/or withdrawal through a metal entry needle or metal dilator may result in destruction and/or separation of the outer polyurethane coating requiring retrieval.A plastic entry needles is recommended when using this wire for initial placement." all available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

• Brand Name: RADIFOCUS GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 6412076
• Report Number: 9681834-2017-00057
• Device Sequence Number: 16419698
• Product Code: DQX
• UDI-Device Identifier: 04987350773197
• UDI-Public: 04987350773197
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 03/16/2017

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: Physician
• Device Model Number: GR3508
• Device Catalogue Number: RF*GA35183A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 03/28/2017
• 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
• Patient Age: 76 YR