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

Model Number N/A

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem Obstruction/Occlusion (2422)

Event Date 08/26/2022

Event Type  malfunction  

Manufacturer Narrative

Brand name: zizai.Product code: kra (zizai's device family, progreat is registered with both dqo and kra).Product code name: catheter, continuous flush.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has been returned for evaluation.Received was the zizai (involved device) and the combination wire.When observing the appearance, the involved device was returned four cut broken pieces of about 3cm to 20cm and a piece of about 150cm on the proximal side.Each of the involved device was severely damaged, and cleaning solution could not be injected into the lumen.For this reason, it was not possible to clean.Since the involved device could not be cleaned properly, it was stored in a zipper bag and the appearance was observed in that state.As a result, several crushing and flattening occurred on both the four broken pieces and a piece of the proximal side, and an overall elongation occurred.When observing the appearance of the combined guide wire was stretched overall, the distal tip cut, and the inner coil was exposed.On the proximal side, the coated resin was torn.In our manufacturing process, we perform visual inspections and dimensional measurement toward zizai by sampling raw materials when received.In addition, we perform visual inspections before assembling to the holder.The device history records of the lot 220201970 were reviewed, and no disorder that may cause the catheter stuck and elongation was found.Result of inspection of manufacturing records, revealed it had no found abnormalities.Based on the above results and the occurrence situation, it was considered that the damages such as elongation, crushing, and cutting which occurred in the involved device might be caused by the tensile load at the removal and the cutting for the removal.However, since the involved device was severely damaged and further investigation could not be performed, we could not identify the cause of the removal defect that occurred in the involved device in this investigation.(b)(4).

Event Description

The user facility reported that the zizai product involved was used in a case of a right coronary artery occlusion to pass the guidewire through the target vessel.After that, the user tried to remove the zizai device, and could not remove it due to resistance.The user tried various methods to remove the zizai, but it could not be removed, therefore the device was surgically removed.

• Brand Name: PROGREAT LAMBDA
• 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, gifu, 501-6 024; JA 501-6024
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 15496318
• MDR Text Key: 306321525
• Report Number: 3009500972-2022-00010
• Device Sequence Number: 1
• Product Code: DQO
• 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: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: NC-C785AM
• Device Lot Number: 220201970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• 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