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

Model Number N/A

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2022

Event Type  malfunction  

Event Description

The user facility reported that the guide wire was inserted into the zizai, however it could not be inserted.When water was injected into the zizai, a resin-like foreign substance came out.Therefore, another zizai was opened, and a foreign object came out of that device as well.

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.Lot number: 220603250, 220603310.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date: 7-july-2022 (220603250), 12-july-2022 (220603310).The actual device was not available; therefore, the actual device will not be 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).

Manufacturer Narrative

This report is being submitted as follow-up no.1 to correct section d9, to provide the device return date in section d9, to update section h3, and to provide the completed investigation results.In the initial report it was reported that the actual device was not available for returned however the actual devices were returned for product investigation.The involved devices were two zizai were returned were returned.The appearance of the returned involved devices was observed while keeping the condition at the arrival, found two kink parts on device #1.On the involved device #2, no abnormalities appearance such as kinks or crushes were observed.Cleaning was conducted, water was injected into the lumen of the device #1, it was not possible to flush normally due to the injection resistance.Next, a metal rod was inserted from the distal tip of the device #1, it was caught at about 4.4cm point from the distal tip and could not be inserted.For this reason, when a part about 5cm from the distal tip of device #1 was cut and a metal rod was inserted from the distal tip of the catheter on the cut side, the foreign substance was pushed out from the lumen of the involved device #1.After cutting device #1, it was flushed again, water was discharged along with a white foreign substance from the cut surface of the catheter on the proximal side.When water was injected into the lumen of the device # 2 there was injection resistance.Pushed further, a white foreign substance was discharged from the distal tip along with water.Visual inspection of the foreign substances was conducted.Two foreign substances were discharged from the involved device #1, foreign substance #1 and foreign substance #2.From device #2 there was one foreign substance discharged, foreign substance #3.When each foreign substance was enlarged and observed, the shape of each foreign substance was thin, flat string-like, entangled and lumped together.The color tone was white translucent, and the total length of the foreign substance #1 was about 0.2cm, the foreign substance #2 was about 0.1cm, and the foreign substance #3 was about 0.3cm.From these properties, it was considered that the foreign substance might be resin.Foreign substance #1 was a thin, flat string of white translucent, entangled and lumped together.Foreign substance #2 was a thin, flat string of white translucent, entangled and lumped together.Foreign substance #3 was a thin, flat string of white translucent, entangled and lumped together.Analysis of foreign substances (were comparison with zizai) was conducted.Based on the characteristics of the appearance of the foreign substances, it was considered that it might be resin, so the analysis of the material using an infrared spectrophotometer was performed.As a result, from the spectrum of the foreign substance, it was inferred that it was ptfe (polytetrafluoroethylene), which is a type of fluororesin.Fluororesin ptfe was used for the inner layer material of our product zizai.Since the foreign substance was ptfe, we inspected the lumen condition of the involved device by the following method to check the possibility that the inner layer material had peeled off.Method: the involved devices #1 and #2 were cut about every 5cm.Each cut catheter was cut in the longitudinal direction, and the lumen condition was observed.Result: when the lumen condition of the cut involved device was observed over the total length, no defects were found that could cause the inner layer material to become a foreign substance, such as scraping or peeling of the inner layer material.After cutting the involved devices #1 and #2 about every 5cm, each cut catheter was cut in the longitudinal direction and the lumen condition was observed.No defects were found that could cause the inner layer material to become a foreign substance, such as scraping or peeling of the inner layer material.No defects were found that could cause the inner layer material to become a foreign substance, such as scraping or peeling of the inner layer material.Simulation test (peeling of inner layer material) was conducted.To inspect the inner surface condition of zizai at when the inner layer material peels off and becomes a foreign substance, the simulation test of peeling of the inner layer material was performed by the following method.Sample: zizai (type: nc-c785am), guide wire runthroughns (type: tw*ds418fh), stainless-steel rod, rod with a rounded end, (outer diameter 0.35mm/0.014inch), and stainless-steel rod, rod with an unrounded end, (outer diameter 0.35mm/0.014inch scalpel.) method: cut out the shaft of zizai about 5 cm and cut it in the longitudinal direction.Scrape the lumen of the cut zizai with the proximal end of the guide wire, the end of the rounded stainless-steel rod, the end of the unrounded stainless-steel rod, and a scalpel.Observe the lumen condition of the zizai after scraping.Result: in the results of using the proximal end of the guide wire and the rounded stainless-steel rod, no abnormalities in appearance such as scratches on the inner layer material were found on the inner surface of the zizai.Next, in the result of using the end of the unrounded stainless-steel rod and the scalpel, the inner layer material of the zizai was scratched, and the braid was deformed along the scratch.In either case, thread-like or band-like foreign substances like foreign substances #1, #2, and #3 did not occur.Test method: proximal end of guide wire - the proximal end of the guide wire was pressed against the inner layer and scraped.Results: no scratches of the inner layer material and the braid disorder.Test method: rounded stainless-steel rod - the end of the rounded stainless-steel rod was pressed against the inner layer and scraped.Results: no scratches of the inner layer material and the braid disorder.Test method: unrounded stainless-steel rod - the end of the unrounded stainless-steel rod was pressed against the inner layer and scraped.Results: the inner layer material was scratched, and the braid was disordered.Test method: scalpel - the tip of the scalpel was pressed against the inner layer and scraped.Results: the inner layer material was scratched, and the braid was disordered.Inspection of manufacturing records were conducted.The device history records of the lot 220603250 and 220603310 were reviewed, and no disorder that may occur the foreign substance found.Since the foreign substance was ptfe, we inspected the lumen condition of the involved device over the total length to check for the possibility that the inner layer material had peeled off.As a result, on the involved devices #1 and #2, no defects were found that could cause the inner layer material to become a foreign substance, such as scraping or peeling of the inner layer material.In either case, thread-like or band-like foreign substances like the foreign substances discharged from the lumen of the involved devices did not occur.Based on the above results, it was considered that the foreign substances discharged from the lumen of the involved device was not a part of our product zizai, such as scraping of the inner layer material of the involved device.However, due to the unknown details of the occurrence situation, the fact that the combination device was not returned, and no further investigation was possible, it was not possible to determine where or under what situation the foreign substance occurred.

• Brand Name: ZIZAI
• 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: 15797484
• MDR Text Key: 307911112
• Report Number: 3009500972-2022-00012
• 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,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• 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: 220603250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2022
• 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