MAUDE Adverse Event Report: TERUMO CLINICAL SUPPLY CO., LTD. PROGREAT LAMDA; MICRO CATHETER SYSTEM

Model Number N/A

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was returned for evaluation.Tcsc received only the catheter of the involved device, terumo microcatheter (hereinafter referred to as the involved device), which was cut into two parts.When observing the appearance of the cut involved device, the total length of the cut catheter on the distal side was 5.8 cm, and the total length of the catheter on the proximal side was 124.8 cm.No abnormalities in appearance such as kinks or crushes were observed.The involved device was cut at 5.8cm point from the distal tip.Involved device: enlarged photo of catheter cutting part (left: distal side / right: proximal side) the involved device was cut at 5.8cm point from the distal tip.Observation of the cut surface when the cut part of the involved device was enlarged, was the cut surface of the catheter tube was flattened to an oval.In addition, the braid was exposed, and the resin and the exposed braid were curved in one direction.The cut surface was flattened to an oval.The resin and braid were curved in one direction.Simulation testing was conducted.The catheter cutting were performed by the following methods using the progreat.Insert the progreat into a two-way stopcock.In that state, rotate the cock of the two-way stopcock to cut it.The progreat was cut into three parts, a catheter piece of about 0.5 cm was made.When observing the cut part of the progreat, no elongation occurred in the resin around the cut part.When observing the cut surface, the cut surface was flattened to an oval, the braid was exposed, and the resin and the braid were curved in one direction.Cut the shaft of the progreat to about 15 cm (hereinafter referred to as the sample).The progreat was cut into three parts, a catheter piece of about 0.5 cm was made.When observing the cut part of the progreat, no elongation occurred in the resin around the cut part.When observing the cut surface, the cut surface was flattened to an oval, the braid was exposed, and the resin and the braid were curved in one direction.When observing the cut part of the sample, the resin around the cut part was stretched.When observing the cut surface, for one of the cut surfaces, the resin was greatly stretched in an irregular direction, and the braid was not exposed.For the other cut surface, the braid was exposed and curved in an irregular direction.The shape of the cut surface was not oval but amorphous.As a result, the cutting that occurred in the involved device was like "cutting with a two-way stopcock." cutting with a two-way stopcock.Cutting with a two-way stopcock.The progreat was cut into three parts.Cutting with a two-way stopcock, side of the cut part (upper: distal side / lower: proximal side).No elongation occurred in the resin around the cut part.Cutting with a two-way stopcock, cut surface (left: distal side / right: proximal side).The cut surface was flattened into a n oval and the braid was exposed.The exposed braid and resin were curved in one direction.Cutting by tensile load.Pull the sample cut to about 15 cm by hand and apply a tensile load.Cutting by tensile load, side of the cut part.Resin elongation occurred around the cut part.Cutting by t ensile load, cut surface.For one of the cut surfaces, the resin was greatly stretched in an irregular direction, and the braid was not exposed.For the other cut surface, the braid was exposed and curved in an irregular direction.In both cases, the shape of the cut surface was not oval but amorphous.Dimension measurement was conducted on the inner and outer diameters of the involved device were measured to confirm the presence or absence of individual abnormalities that may cause catheter cutting, such as the thinness of the resin.As a result, the inner and outer diameters of the involved device were within our standard values, and no abnormalities such as the thinness were observed.Inspection of manufacturing records in our manufacturing process, perform visual inspections toward all progreat before assembling to the holder.The device history records of the lot 211103820 were reviewed, and no disorder that may cause the catheter cutting was found.The presumed cause is that the involved device was cut into two parts, and only the catheter was returned.When the cut part of the involved device was enlarged and observed, the cut surface of the catheter tube was flattened to an oval.In addition, the braid was exposed, and the resin and the exposed braid were curved in one direction.In the simulation tests, the stopcock was set on the progreat, and when the stopcock was operated, the progreat was cut into three parts.When observing the cut part of the progreat, the cut surface was flattened to an oval similar to the involved device, the braid was exposed, the resin and the braid were curved in one direction.From the results of dimension measurement and inspection of manufacturing records, it was not found any abnormalities that could result in catheter cutting.From the above results, it was considered that the catheter cutting which occurred in the involved device might be caused by the stopcock operation while it was inserted into the combination angiographic catheter.

Event Description

The user facility reported that the procedure performed used the involved progreat lamda device.The combination guide wire was set on the involved device, the user tried to remove it from the angiographic catheter, the involved device was torn off.Additional information was received (b)(6) 2020 the procedure was a stemi and this event occurred as the doctor attempted to do aspiration thrombectomy.

• Brand Name: PROGREAT LAMDA
• Type of Device: MICRO CATHETER SYSTEM
• 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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 14623083
• MDR Text Key: 301594822
• Report Number: 3009500972-2022-00002
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: CC-M1913S
• Device Lot Number: 211103820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2021
• 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