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

Model Number N/A

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 11/01/2019

Event Type  Injury  

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 not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.We investigated the complaint records of the lot 190100600, and we found no same kinds of complaints were reported in the past.The device history records of lot 190100600 were reviewed, and no disorder was found.(b)(4).

Event Description

The user facility reported that the product was used to aspirate a thrombus.When thrombus was aspirated using the product, there was resistance and could not be aspirated.After confirming the blood vessel, it had dissection.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation results.The involved device (eliminate) was not return to the manufacturer, therefore we couldn't perform the observation.In the past references there is a case report that coronary dissection occurred by using the another manufacturer's thrombus aspiration catheter.In this case report, it is reported that the aspiration while the distal tip of thrombus aspiration catheter is in contact with vessel wall may cause the stripping of the intima layer might be caused by suction pressure.Coronary artery dissection after the use of the thrombus aspiration catheter in anterior st-elevation myocardial infarction.Based on this report, it was considered that the blood vessel was dissociated due to the aspiration while the distal tip of the thrombus aspiration catheter was in contact with the vessel wall in this case as well.

• Brand Name: ELIMINATE PLUS
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): TERUMO CLINICAL SUPPLY CO., LTD.; 3 kawashima-takehaya-machi; kakamigahara,; gifu, 501-6 024,; JA 501-6024,
• MDR Report Key: 9530569
• MDR Text Key: 182572109
• Report Number: 3009500972-2019-00005
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: EL-G1702
• Device Lot Number: 190100600
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other