MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M

Model Number	GR3503
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: udi - not required for the reported product code/lot number combination, however, the di portion was provided.H6 - results - 3252 is based on evaluation of user facility information & the returned sample; 213 is based upon evaluation of undamaged sections of the returned sample.H6 - conclusion - 77 is based upon evaluation of user facility information & the returned sample; 71 is based upon evaluation of undamaged sections of the returned sample.Visual inspection upon receipt revealed that the core wire was exposed on 0mm - 40mm from the distal end of the device.On 0mm - approximately 235mm and on approximately 235mm - 465mm from the distal end of the device, the urethane outer layer was noted to have been sheared off the core wire.Magnifying inspection of the urethane-sheared segments revealed the following.On 0mm - 40mm from the distal end of the device, the urethane outer layer was completely missing.On 0mm - approximately 235mm and on approximately 235mm - 465mm from the distal end of the device, the urethane outer layer had been sheared off the core wire half-circumferentially, where the core wire was partially exposed.The surface of the sheared urethane layer was in the smooth state.The outside diameter was measured on the undamaged segment and confirmed to meet manufacturer specification.The distal extremity of the core wire was inspected under electron microscope.It was conformed to be in the state similar to that of the current product sample, presenting the evidence that the core wire had been cut and processed with the dedicated machine properly on the production floor.The outside diameter of the core wire was confirmed to meet manufacturer specification.The sheared urethane segments revealed the following.Hereinafter the two samples are called segment 1 and segment 2 in this report.Segment 1 measured approximately 200mm and segment 2 measured approximately 230mm in the total length.Magnifying inspection revealed the following.Segment 1, on 0mm - 40mm from the distal end of the device there was no missing portion.At approximately 40mm from the distal end it had the trace of ripping.On approximately 40mm - 200mm the half circumferential portion was missing with a groove on the rest of the segment.It had a sharp cut cross section at one end.Segment 2, along the total length, the half circumferential portion was missing with a groove on the rest of the segment.The findings above found that the total length of segment 1 and segment 2 was equivalent to the length of the segment of the guide wire where the urethane outer layer is missing.(on 0mm - approx.200mm and approx.235mm - 465mm from the distal end of the device).Therefore, it is most likely that there is no portion missing from the guidewire.Functional testing was conducted on a guidewire sample and could not reproduce the reported defect.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined, however based on the investigation result, it is likely that the actual sample was withdrawn through the involved metallic device such as a metallic needle resulting in the reported shearing of the urethane outer layer.The device labeling does address the potential for such an event in the instruction for use (ifu) with the statement such as the following: "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." a review of the device history record and the shipping inspection record of the involved product code/lot # combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/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.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 an issue with the involved guidewire device.Follow up communication with the user facility confirmed the following information: it shredded in three spots then broke off; and occurred pre-treatment and no patient was involved.

• Brand Name: RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 6601405
• Report Number: 9681834-2017-00119
• Device Sequence Number: 16224438
• Product Code: DQX
• UDI-Device Identifier: 04987350773098
• UDI-Public: 04987350773098
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 05/31/2017

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: 01/31/2018
• Device Model Number: GR3503
• Device Catalogue Number: RF*GS35183A
• Device Lot Number: 160201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR