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

Model Number N/A

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

The user facility reported that when the user used the involved zizai device, the guidewire penetrated the side of the zizai.

Manufacturer Narrative

This report is being sent as follow-up no.1 to update section h3, and to provide the completed investigation results.Only the involved device, zizai (hereinafter referred to as the "involved device") was returned.Visual inspection of the returned involved device, the perforation of the catheter was found at the point of 0.6 cm from the distal tip.No abnormalities were found in other parts.When this perforation was enlarged and observed, the resin near the perforation stretched from the inside to the outside, toward the proximal side.In addition, the braid near the perforation was spread out and the braid was pushed apart.A kinked deformation occurred on the back side of the perforation.From these results, it was presumed that the perforation that occurred in the involved device may have occurred while the braid was being spread out by applying a local load from the inside toward the proximal side.Simulation testing was conducted.It was presumed that the perforation that occurred in the involved device may have occurred while the braid was being spread out by applying a local load from the inside toward the proximal side.Simulation tests of the perforation that occurred in the involved device were performed by the following (1) & (2) methods.(1) method - insert the metal rod with the catheter bent.Sample: zizai stainless-steel metal rod (outer diameter: 0.35mm / 0.014 inch).Method: bend and fix the part of about 0.4 cm from the distal tip of the sample.In that state, insert a stainless-steel metal rod into the sample from the distal side.Result: a stainless-steel metal rod was inserted into the sample, and even after the tip of the metal rod reached the kink part of the sample, it was pushed in.As a result, the metal rod pierced the kink part of the sample and perforated.When the perforated part of the sample was enlarged and observed, similar to the involved device, the resin near the perforation was stretched from the inside to the outside toward the proximal side.(2) method - apply pressure with the distal tip of the catheter sealed.Sample: progreat.Method: inject purified water into the sample and fill the lumen with purified water.Bend the distal tip of the sample and seal it with a vise.In that state, immerse the sample in hot water at 37 °c for at least 2 minutes.While still immersed in hot water, use a 1 ml syringe to manually push the plunger to inject purified water into the sample.Result: when purified water was injected into a sample immersed in hot water in a sealed state with a 1 ml syringe, the tube of the sample inflated.When the inflated part of the sample was enlarged and observed, unlike the perforated part of the involved device, the outer layer material was torn and there was a permanent elongation as if it had inflated from the inside and burst.From the results of the simulation tests (1) and (2), the reproducibility of perforation similar to that of the involved device was confirmed by inserting the guide wire with the catheter bent.Dimension measurement of the involved device were measured for the following purposes.Total length measured to check for elongation that has occurred in the involved device.Inner and outer diameters to check for abnormalities that may cause the perforation of catheter, such as thin resin walls.As a result, the inner and outer diameters of the distal and proximal side of the involved device were within our standard values, and no abnormalities were observed.Inspection of manufacturing records in our manufacturing process, we perform visual inspections toward all zizai before assembling to the holder.Visual inspections and dimension measurements, are also performed for each manufacturing lot.The device history records of the lot 230602620 were reviewed, and no disorder that may cause the perforation of the involved device was found.Presumed cause when we observed the returned involved device, the perforation of catheter was found at the point of 0.6 cm from the distal tip.When this perforation was enlarged and observed, the resin near the perforation stretched from the inside to the outside, toward the proximal side.In addition, the braid near the perforation was spread out and the braid was pushed apart.When the simulation test of a perforation was performed and a metal rod was inserted into the sample in which the kink was prepared, the similar perforation reproducibility to the involved device was confirmed.As a result of the dimension measurement, the inner and outer diameters of the distal and proximal side of the involved device were within our standard values, and no abnormalities were observed.As a result of the inspection of manufacturing records, no disorder that may cause the perforation of the catheter was found.From these results, it was presumed that the perforation that occurred in the involved device may have occurred while the braid was being spread out by applying a local load from the inside toward the proximal side.When the involved device was set from the rear end of the combination guide wire, it was considered that the local load applied to the involved device may have been caused by the insertion with the catheter bent, or by pushing in the combination guide wire in a state where there was resistance to passage such as kinking or bending.

• 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: 18490389
• MDR Text Key: 332997334
• Report Number: 3009500972-2023-00009
• 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: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 230602620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2023
• 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