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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 05/23/2022

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Establishment name: (b)(6).Visual inspection for the involved device, only zizai (hereinafter referred to as the involved device) was returned.When observing the appearance of the involved device, there were one perforation and two crushes.Crushes were observed at points of 4.8 cm and 10.6 cm from the distal tip.A perforation was observed at the point of 0.5cm from the distal tip.Distal part of the involved device was a perforation at the point of 0.5cm from the distal tip.Perforation of the involved device, in the perforated part, the resin was stretched from the inside to the outside and the braid was deformed.In addition, a kink-like deformation was observed on the back side of the perforated part.Observation of the perforation in the involved device was enlarged and observed, the resin near the perforation was stretched from the inside to the outside toward the proximal side.In addition, the braid near the perforation was spread out.From these facts, 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.Using the sample guide wires, the size of the perforation that occurred in the involved device was compared.As a result, the size of the perforation that occurred in the involved device was smaller than the outer diameter of the 0.012-inch guide wire and was close to the outer diameter of the 0.010-inch guide wire.Sample: guide wire radifocus guidewire m rg-ga1218s (0.012inch) asahi rg3 ah10s302sr (0.010inch).Perforation at 0.5 cm from the distal tip, enlarged, the braid near the perforation was spread out.Perforation at 0.5 cm from the distal tip, electronic microscope photo the resin near the perforation was stretched from the inside to the outside toward the proximal side.Comparison of perforation part of the involved device + 0.012-inch guide wire.The perforation that occurred in the involved device was smaller than the outer diameter of the 0.012-inch guide wire.Comparison of perforation part of the involved device + 0.010-inch guide wire.The perforation that occurred in the involved device was close to the outer diameter of the 0.010- inch guide wire.Simulation test 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.The perforation that occurred in the involved device was close to the outer diameter of the 0.010-inch guide wire.Simulation tests of the perforation that occurred in the involved device were performed by following methods.[1] 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.Simulation test method: insert a stainless-steel metal rod: bend and fix the part of about 0.4 cm from the distal tip of the sample.Simulation test result: when a stainless-steel metal rod was pushed into the sample, the metal rod pierced and perforated the kink part of the sample.The sample of the simulation test, a perforation was found at the point of 0.4 cm from the distal tip.Also, the braid near the perforation was spread out.Simulation test result, electronic microscope photo: the perforation that occurred in the sample of the simulation test showed deformation of the resin from the inside to the outside.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, the outer layer material was torn like the inflated part of the involved device, and there was a permanent elongation as if it had inflated from the inside and burst.Simulation test method (sealing of distal tip):bend the distal tip of the sample whose lumen is filled with purified water and seal it with a vise.Simulation test method (immersion of sample): immerse the sample with the sealed distal tip in hot water.Simulation test method (pressurization to the sample).Push the plunger of a 1ml syringe manually and inject purified water into the sample whose distal tip is sealed.Simulation test result, deformed part of sample (upper: side / lower: front).The outer layer of the catheter was deformed as if it had inflated.The resin of the torn outer layer material had 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 the dimensions of the involved device were measured for the following purposes: - inner and outer diameters: inspection of the possibility that perforation has occurred in the catheter due to the thinness of resin, etc.As a result, the inner and outer diameters of the distal and proximal part of the involved device were within our standard values, and no abnormality was found.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, etc.Are also performed for each manufacturing lot.The device history records of the lot 220200240 were reviewed, and no disorder that may cause the perforation of the involved device was found.When observing the appearance of the involved device, there were one perforation and two crushes.When the perforation that occurred in the involved device was enlarged and observed, the resin near the perforation was stretched from the inside to the outside toward the proximal side.In addition, the braid near the perforation was spread out.Comparing the size of the perforation that occurred in the involved device using the sample guide wires, the perforation that occurred in the involved device was close to the outer diameter of the 0.010- inch guide wire.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 dimension measurement, the inner and outer diameters of the distal and proximal part of the involved device were within our standard values, and no abnormality was found.As a result of the inspection of manufacturing records, no disorder that may cause the perforation of the catheter was found.From these facts, 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.(b)(4).

Event Description

The user facility reported that when the contrast medium was injected into the involved device, it seemed that the contrast medium was leaking out from the part other than the distal tip.The catheter was replaced considering the possibility of a hole somewhere in the involved device.

• 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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 14800416
• MDR Text Key: 302680567
• Report Number: 3009500972-2022-00004
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• 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-C785AM
• Device Lot Number: 220200240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• 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