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

Model Number N/A

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2022

Event Type  malfunction  

Event Description

The user facility reported that the zizai product involved was used, the guide wire penetrated the side of zizai.The zizai was bent at a right angle as the guide wire with a stiff tip was used, it was thought that it hit and penetrated.

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 was not returned; therefore, an evaluation of the actual device was unable to be conducted.The device history records of the lot 210800390 were reviewed, and no disorder that may cause the poor removal of the involved device was found.We inspected the trend abnormalities for this product, and no trend abnormalities related to the poor removal occurred in the past.Since the involved device was not returned and no abnormality was found from the investigation results, we could not identify the cause of the poor removal that occurred in the involved device.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).

• 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: 15496192
• MDR Text Key: 301162470
• Report Number: 3009500972-2022-00011
• 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: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: NC-C783AM
• Device Lot Number: 210800390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• 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