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

Model Number N/A

Device Problems Difficult to Remove (1528); Stretched (1601); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2023

Event Type  malfunction  

Event Description

The user facility reported that when the product was used to advance into the blood vessel, the distal tip of the product was pierced into the lesion part.Therefore, when the product was tried to be removed, there was a removal resistance, and the distal tip of the product got stuck.When the product was pulled more strongly, it was pulled out while being stretched, and could be removed.

Manufacturer Narrative

A1: patient identifier: requested, not provided a2: age & date of birth: requested, not provided a3: patient sex: requested, not provided a4: weight: requested, not provided a5: ethnicity: requested, not provided a6: race: requested, not provided d6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e1: initial reporter name: requested, unknown the actual device has been returned for evaluation.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).This reported event was unable to be submitted on (b)(6) 2023 due to a esg server issue, timely filing attempts were documented and have been attached.

• 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: 17284959
• MDR Text Key: 319392058
• Report Number: 3009500972-2023-00005
• 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: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2023
• 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: 230103060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2023
• 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