MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RUNTHROUGH NS; WIRE, GUIDE, CATHETER

Model Number	TW*DS418FH
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Codes	Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Race - requested, not provided.Implanted date: device was not implanted.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.A review of the device history record and the shipping inspection record of the involved product code/lot# combination was conducted with no findings.Please see mdr 2243441-2019-00095 for the importer report.
Event or Problem Description
The user facility reported that while approaching a coronary, in-stent restenosis, in the left main, the 180 cm length run through hyper coat became caught/jailed behind the stent strut as the wire was advanced; subsequently the wire separated approximately 10 cm from the distal tip of the wire.The remainder of the proximal aspect of the wire was removed; however, the distal segment of the wire remains lodged behind the stent strut and left main vessel wall.Additionally, the remaining proximal segment of the wire is circling the opposing, contralateral aortic root.A snare was used to snare the wire and retrieve without success.The patient was turned down for surgery.Another attempt to retrieve the wire may be made on a later date.Blood loss was less than 250 cc.The patient's condition was stable.Calcified vasculature, previous by-pass patient, left main in-stent restenosis.The procedure outcome was unsatisfactory.Additional information was received on 09sep2019.The procedure to remove the wire was performed on (b)(6) 2019, with partial retrieval of the spring coil segment of the wire.The remaining distal segment of the wire would not release from the stent strut.The attending physician chose to stent over and oppose the wire up against the wall of the left main segment of the artery.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d10, update section h3, and to provide the completed investigation results.The actual device was received for evaluation.Visual inspection revealed that the returned sample was the piece of coil that had been retrieved with a snare.The total length of the coil was unable to be measured since the coil had been entangled.The rest part of the actual guide wire sample was not returned; thus, it was unclear whether there was any missing portion.Magnifying and electron microscopic inspection of the actual coil sample revealed that both ends had been deformed in a tapered shape.From this, it is inferred that the actuals coil sample was exposed to some pulling force.The surface of the actual coil sample was subjected to constituent analysis by sem-edx and confirmed to contain platinum as the main component.In addition, carbon and nickel were noted.Based on this, the actual coil sample was most likely to be a fractured platinum coil.The outer diameter of the actual coil sample was measured and confirmed to be equivalent to that of the platinum coil of a factory-retained runthrough ns sample; o/d of the actual coil sample: 0.066mm, o/d of the platinum coil of the factory-retained runthrough ns sample: 0.066mm.Reproductive testing was performed, and a platinum coil unraveled from a test sample was subjected to pulling force.As a result, the coil became fractured and both fracture ends were found to have been deformed in a tapered shape.Ifu states: manipulate the runthrough ns carefully when crossing it through a deployed stent.Stent migration, stent deformation, or breakage or separation of the runthrough ns may be caused if the runthrough ns is caught by the deployed stent.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the distal segment of the platinum coil of the actual sample was trapped in the stent strut due to some factors; when the actual sample in that state was exposed to excessive pulling or torque force, the niti core wire inside the platinum coil became broken off, and subsequently, the actual sample was subjected to further pulling force, resulting in the platinum coil getting fractured.However; without the return of the rest of the actual guidewire including the core wire, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: RUNTHROUGH NS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9110972
• Report Number: 9681834-2019-00167
• Device Sequence Number: 3173624
• Product Code: DQX
• UDI-Device Identifier: 04987350720986
• UDI-Public: 04987350720986
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063695
• 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): 09/24/2019

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: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: TW*DS418FH
• Device Catalogue Number: 25-3011
• Device Lot Number: 190124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 10/17/2019
• 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: CORONARY GUIDE; SUPPORT CATHETER
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 71