MAUDE Adverse Event Report: TERUMO CLINICAL SUPPLY CO., LTD. ELIMINATE PLUS; CATHETER, EMBOLECTOMY

Catalog Number	EL-G1702
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi - not required for this product code/ lot number combination.Implanted date: device was not implanted.Explanted date: device was not explanted.Not required for this product code/ lot number combination.The actual device was returned for evaluation.Visual inspection revealed that the tore was from the exit port to the distal end side at 6.7cm~8.5cm from the tip.Simulation testing was performed by using a new eliminate and ptca trainer.As these result, tore of exit port in involved product occurred by the reason that removal operation was performed in the state of bending of guidewire used together.A review of the device history record of the product code/lot# combination was conducted with no relevant findings.Terumo medical products (tmp)(importer) registration no.2243441 is submitting this report on behalf of terumo clinical supply co., ltd.(manufacturer) registration no.3009500972.Exemption number e2015021.
Event or Problem Description
The user facility reported that when the user was using the eliminate, the guidewire was trapped and stacked.Therefore the eliminate stopped moving, and another product was used.

• Brand Name: ELIMINATE PLUS
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): TERUMO CLINICAL SUPPLY CO., LTD.; 3 kawashima-takehaya-machi; kakamigahara, japan 501-6 024; JA 501-6024
• MDR Report Key: 8387692
• Report Number: 3009500972-2019-00001
• Device Sequence Number: 19345638
• Product Code: DXE
• UDI-Device Identifier: 04543334177254
• UDI-Public: 04543334177254
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2019

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: 08/31/2021
• Device Catalogue Number: EL-G1702
• Device Lot Number: 180901860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1