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

Model Number	RF*GA35263A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A6: race - requested, not provided 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 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 the customer called and said part of the wire broke off while pulling out of patient.Blood loss was reported to be less than 250 cc.The patient was reported to be in stable in condition.The procedure outcome was reported to be good.No patient injury or medical intervention.Additional information was received on 11/20/18.The procedure being performed was a post peripheral angiogram.The wire did not break, and it was the coating.An x-ray matched the fragment with wire.The wire was removed from the patient through the catheter.There were no other devices or equipment being used with the reported product such as metal devices or metal entry needles.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date and provide the completed investigation results.The actual sample was returned for evaluation.Visual inspection upon receipt revealed that the urethane outer layer had been sheared off on approximately 1130 -1160mm from the distal end of the device, approximately 30mm in length, where the core wire was noted to be exposed.Magnifying inspection revealed the following.The edges of the urethane outer layer were sheared.A flaw was found on the urethane outer layer at approximately 1128mm from the distal end of the device.On approximately 1163 - 1165mm from the distal end of the device, the urethane outer layer was found to have been sheared along the total circumference, where there was no exposure of the core wire.The outside diameter was measured on the undamaged section and confirmed to meet manufacturer specifications.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 exposed to excessive abrading force generated by a metal device, including a metal torque device, used in combination with the actual sample.However, the reported event cannot be definitively determined based on the available information.The ifu states: "do not use a metal torque device with the glidewire.Use of a metal torque device may result in damage to the glidewire.Do not use the glidewire 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.".

• 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: 8120722
• Report Number: 9681834-2018-00212
• Device Sequence Number: 207523
• Product Code: DQX
• UDI-Device Identifier: 04987350773210
• UDI-Public: 04987350773210
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/30/2018

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: 04/30/2020
• Device Model Number: RF*GA35263A
• Device Catalogue Number: GR3509
• Device Lot Number: 180514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1