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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiogenic Shock (2262); Thrombosis/Thrombus (4440)

Event Date 07/25/2021

Event Type  Death  

Manufacturer Narrative

Patient identifier - requested, not provided.Age & date of birth - born in (b)(6).Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- is a product not shipped to the united states.Therefore, pma / 510 (k) has not been obtained for this product.The actual device was not returned for evaluation, therefore we performed the following investigation.We investigated the complaint records of the lot 200901270, and we found no same kinds of complaints were reported in the past.We inspected the trend abnormalities of eliminate ppr (after april 2020), and no trend abnormalities of eliminate ppr occurred during this period.We investigated the ncr of eliminate and inspected for abnormalities in the manufacturing process (after april 2020).As a result, there were no abnormalities that cause poor aspiration during the period.We perform visual inspections toward all eliminates.The device history records of lot 200901270 were reviewed, and no disorder that causes poor aspiration was found.Based on the past experience, it is known that eliminate may not be able to successfully aspirate the thrombus if the catheter is kinked or crushed.However, we could not identify the cause of the following reasons.The involved device was not returned and we couldn't perform the detailed investigation.It occurred with normal usage.Details of the occurrence situation were unknown.No abnormality was found in the trend analysis and the manufacturing record.(b)(4).

Event Description

The user facility reported that the doctor experienced a failed thromboaspiration attempt with the eliminate catheter.The patient had a large thrombus in the common trunk of the left coronary.The patient was in cardiogenic shock and they were unable to aspirate the clot.It migrated distal to the intraoperative vascular angiography (iva) and the circumflex network, after placing two angioplasty guides, one in the distal via and one in the distal circumflex prior to using the eliminate.

• Brand Name: ELIMINATE
• 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
• Manufacturer (Section G): TERUMO CLINICAL SUPPLY CO., LTD.; reg. no. 3009500972; 3 kawashima-takehaya-machi; kakamigahara, 501-6 024; JA 501-6024
• Manufacturer Contact: mary o'neill ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12376008
• MDR Text Key: 268422410
• Report Number: 3009500972-2021-00001
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/27/2021

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: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: EG1602
• Device Lot Number: 200901270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 48 YR