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

Model Number	RF*GA35083A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2018
Type of Reportable Event	Malfunction
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 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.- attachment: [uf mw330140-2018-18.Pdf].
Event or Problem Description
A user facility medwatch (b)(4) was received by terumo on december 20, 2018 and reported the following: the user facility reported that the radifocus glidewire uncoiled while the patient was in the operating room for a pacer wire insertion.There was no harm to the patient.
Additional Manufacturer Narrative
The actual sample was received for evaluation.Visual inspection revealed that the urethane outer layer had been sheared off on approximately 134 - 238mm from the distal end of the device.Magnifying inspection of the urethane outer layer; sheared section revealed the following: the urethane outer layer had been semi-circumferentially sheared off the wire, with the core wire being exposed.The shear cross-section of the urethane outer layer was in the smooth state, implying that it had been cut with a cutting tool.The outside diameter was measured on the undamaged section and confirmed to meet manufacturer specifications.Ifu states: 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.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 a metal dilator may result in destruction and/or separation of the outer polyurethane coating requiring retrieval.A plastic entry needle is recommended when using this wire for initial placement.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely the actual sample may have been withdrawn through a metallic needle in the manner of it having contact with the metallic needle, resulting in shearing of the urethane outer layer.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• 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: 8228096
• Report Number: 9681834-2018-00239
• Device Sequence Number: 1592777
• Product Code: DQX
• UDI-Device Identifier: 04987350778376
• UDI-Public: 04987350778376
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2019

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: 07/31/2019
• Device Model Number: RF*GA35083A
• Device Catalogue Number: GR3513
• Device Lot Number: 170830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 01/08/2019
• 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