MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GUIDEWIRE

Model Number	GR3506
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2017
Type of Reportable Event	Malfunction
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.A review of the device history record and the product release decision control sheet of the product code/lot# combination was conducted with no relevant findings.A search of the complaint file did not find any 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 shearing of the wire during a dx cath procedure.Follow up communication with the user facility confirmed the following information: after diagnostic angiography the wire was removed from the body; the wire was noted to be sheared and close to breaking off about 10 cm from the distal (angled) end; the procedure was completed; and there was no patient injury or medical intervention required, patient is doing okay.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the returned sample evaluation results.Visual inspection upon receipt revealed that the urethane outer layer had been sheared off the core wire on the segment approximately 183mm -193mm from the distal end of the shaft.The actual sample was measured for the total length and it was determined there is no missing portion on the actual sample.Magnifying and electron microscopic inspections revealed that the shear cross-section surface was in the smooth state.The portion detached from the core wire had a semi circler groove on the surface in the lengthwise direction.The outer diameter of the shaft was measured on the undamaged segment and confirmed to meet manufacturer specification.Functional testing was conducted: a test sample was withdrawn through a metal needle and the urethane outer layer sheared off, with the surface of the sheared segment being in a smooth state.The state of the fracture was similar to the actual sample.There is no indication that this event was related to a device defect or malfunction and the exact cause cannot be definitively determined.Based on the investigation results it is likely that the actual sample was pulled through a metal device in the proximal direction in the state of having contact with the edge of the metal device, resulting in the shearing the urethane layer off the shaft.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 guide wire m 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." all available information has been placed on file in quality assurance at the manufacturing facility 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: 6421552
• Report Number: 9681834-2017-00056
• Device Sequence Number: 18964930
• Product Code: DQX
• UDI-Device Identifier: 04987350773159
• UDI-Public: (01)04987350773159(17)180930(10)161004
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 03/21/2017

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: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: GR3506
• Device Catalogue Number: RF*GA35153A
• Device Lot Number: 161004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 04/13/2017
• 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: DIAGNOSTIC CATHETERS; DIAGNOSTIC CATHETERS