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

Model Number N/A

Device Problems Difficult to Insert (1316); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 03/20/2023

Event Type  malfunction  

Event Description

The user facility reported that when the involved product was inserted into the target blood vessel, it became stuck and could not be pushed or pulled.The guide wire used in combination was able to move, so the operation of the guide wire was continued, but soon the guide wire also could not be moved.Therefore, a guidewire was newly inserted, and expanded with a balloon from the side of the stuck item, however the stuck could not be improved.The product was tried to be removed again, but the product was torn off in the middle.The torn tip side was collected with a snare.The target blood vessel was calcified, and a stent had been placed on the nearer side of the target blood vessel.It was considered that the product was got stuck due to a calcified lesion or a stent.

Manufacturer Narrative

The actual device was not available for return; therefore, an evaluation of the actual device was unable to be conducted.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.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: ZIZAI
• Type of Device: MICRO CATHETER SYSTEM
• Manufacturer (Section D): TERUMO CLINICAL SUPPLY CO., LTD.; 3 kawashima-takehayamachi; 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: 16767920
• MDR Text Key: 313566078
• Report Number: 3009500972-2023-00001
• 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: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• 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: NC-C783AM
• Device Lot Number: 221102110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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