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

Model Number	TW*DS418FH
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, the product release judgement, and the shipping inspection record of the involved product code/lot# combination was conducted with no findings.Please see mdr (b)(4) for the importer report.(b)(4).
Event or Problem Description
The user facility reported that the involved runthrough device was used during the procedure and separated on withdrawal.The patient's condition was reported good and was doing fine.The procedure outcome was good.The estimated blood loss was less than 250cc.There was no patient injury, medical/surgical intervention required.Additional information was received on 10jun2020.There was no part left in the patient.The procedure being performed was a coronary angioplasty.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.A guidewire was returned for investigation; however, it was found that the returned guidewire was not an ashitaka-made product.No runthrough ns sample has been returned for evaluation.Inspection of the returned guidewire was performed.Visual inspection revealed that the distal end of the coil had been fractured.Magnifying inspection of the returned guidewire found it was different from a factory retained runthrough ns in the following points: color of the ptfe coating on the shaft, returned guidewire: black; runthrough ns: blue.Form of joint between the proximal end of the coil and the core wire: returned guidewire: stepped, runthrough ns: tapered.Form of the extension-wire connector: returned guidewire: wavy with two peaks, runthrough ns: wavy with four peaks.Based on the inspection findings, it was verified that the returned guidewire was from another brand.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.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.If any resistance to the runthrough ns or the dilatation catheter is felt during manipulation or if the shape, behavior or position of the guide wire's tip seems improper, e.G., in case where the tip is trapped due to vessel spasm or some other cause or the tip is folded, stop manipulating the guide wire (and the catheter) and determine the cause carefully by fluoroscopy and take suitable remedial actions.Then remove the guide wire slowly, without turning, to exchange it for a new one.Continuing guide wire or catheter manipulation in the said situations may result in damage to the vessel, damage to or separation of the guide wire's tip, and/or damage to the dilatation catheter.When selecting the vessel in which the runthrough ns is to be inserted or when[?]advancing the guide wire through the stenosis, do not turn the proximal end of the guide wire three or more turns in succession in the same direction if the guide wire's tip is trapped.Separation of the guide wire may result.With no return of the actual device, 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: 10189412
• Report Number: 9681834-2020-00116
• Device Sequence Number: 11445577
• Product Code: DQX
• UDI-Device Identifier: 04987350720986
• UDI-Public: 04987350720986
• Combination Product (Y/N): N
• 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): 06/24/2020

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: 07/31/2022
• Device Model Number: TW*DS418FH
• Device Catalogue Number: 25-3011
• Device Lot Number: 190809
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other