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

Model Number N/A

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Insufficient Information (4580)

Event Date 11/14/2022

Event Type  malfunction  

Manufacturer Narrative

Only the catheter of the involved device was returned.When the appearance was observed, the gw lumen had about a 1.3cm tear from the exit port toward the distal tip.In addition, the catheter kink was found near the rear end of the gw lumen, and the crushing was found in three places from the distal tip: 121.7cm, 123.0cm, and 123.7cm.It was presumed that the tear of the gw lumen of the involved device was caused by the load from the inside of the gw lumen as the resin stretched outward from the inside.Simulation test was conducted.The simulation tested the tear of the gw lumen of the involved device using the eliminate and ptca trainer.Method of testing: 1) set the compatible size guide wire to the eliminate and insert it into the ptca trainer with the compatible size guiding catheter.2) operate the guide wire to form a loop on the combined guide wire.3) in that state, perform the removal operation of eliminate.Result: as a result of observing the exit port of the eliminate, a tear very similar to the involved device was found.From the above results, it was presumed that the tearing of the exit port that occurred in the involved device was due to the loop of the combined guide wire near the exit port and the removal operation in that state.The guide wire loops at the distal part of the guiding catheter, causing resistance.Pulling the catheter in stuck and loop state breaks the guide wire and damages the exit port.To check the following possibilities, we inspected the inner and outer diameter dimensions of the involved device.Possibility of thinness of catheter, catheter kink or crushing as a result, due to the crushing of the guide wire lumen, the pin gauge could not pass through, and the inner diameter could not be measured.The inner and outer diameters of other parts of the involved device are within our standard values, and no abnormalities were found.Inner diameter of main lumen: standard value - 1.09mm*1 / measured value - pin gauge passed through.Inner diameter of guide wire lumen: standard value - 0.40mm*1 / measured value - pin gauge passed through.Outer diameter of distal tip: standard value - 1.78mm*2 / measured value - passed outer diameter of proximal part: standard value - 1.40mm ± 0.03mm / measured value - 1.39mm.The distal tip of the involved device passed through the outer diameter inspection jig without resistance.For the involved product eliminate, we perform dimension measurements, by sampling each tube raw material lot and manufacturing lot.In addition, we perform visual inspections toward all eliminate before assembling to the holder.The device history records of the lot 210802540 were reviewed, there were no abnormalities in the results of each inspection.No abnormalities such as inner and outer diameter abnormalities that could lead to guidewire lumen tearing, catheter kink or crushing were observed as a result of the appearance observation of the involved device, the gw lumen had the about 1.3cm tear from the exit port toward the distal tip.It was presumed that the tear of the gw lumen of the involved device was caused by the load from the inside of the gw lumen as the resin stretched outward from the inside.In other parts, there was no abnormality of appearance such as kink or crushing.In the simulation test, when the removal operation of the eliminate with the guide wire forming a loop was performed, the tear from the exit port toward the distal tip like the involved device was occurred.For the dimension measurement and the manufacturing record inspection, no abnormalities that could cause the aspiration failure or tearing of the gw lumen were found.From the above results, it was presumed that the tearing of the gw main lumen that occurred in the involved device was due to the loop of the combined guide wire near the exit port and the removal operation in that state.Terumo medical products (tmp)(importer) registration no.(b)(4) is submitting this report on behalf of terumo clinical supply co., ltd.(manufacturer) registration no.(b)(4).

Event Description

The user facility reported that when eliminate device involved was advanced into the patient's narrowed blood vessel the eliminate device kinked.

• 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,
• Manufacturer (Section G): TERUMO CLINICAL SUPPLY CO., LTD.; reg. no. 3009500972; 3 kawashima-takehaya-machi; kakamigahara, gifu, 501-6 024; JA 501-6024
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 15971705
• MDR Text Key: 308202097
• Report Number: 3009500972-2022-00013
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: EL-G1702
• Device Lot Number: 210802540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2021
• 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): Congenital Anomaly