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

Model Number N/A

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Insufficient Information (4580)

Event Date 07/18/2023

Event Type  malfunction  

Manufacturer Narrative

The actual zizai device has been returned for evaluation.The involved device was observed while keeping the condition at the arrival, observation at cleaning for the involved device, observed the catheter kink found at the point of 0.5 cm from the distal tip.In addition, the tip marker and tip of the involved device were crushed.To clean the involved device, a syringe was used to inject water.However, there was resistance to water injection, and since it could not be injected normally, the involved device could not be cleaned normally.Visual inspection was conducted.When we observed the returned involved device, the catheter kink was found at the point of 0.5 cm from the distal tip.When this kink was enlarged and observed, it was perforated with the resin elongation from the inside to the outside and the breakage of the braid.In addition, a foreign substance was found in the lumen at the point of about 7 cm from the distal tip of the involved device.It was inferred that the water injection resistance to the involved device may have been caused by this foreign substance.Based on the occurrence situation provided and appearance observations, it was considered that a thrombus, etc.Were clogged in the lumen of the involved device.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 following methods: [1] insert the metal rod with the catheter bent: sample: zizai - stainless-steel metal rod (outer diameter: 0.35 mm / 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, like the involved device, the resin near the perforation was stretched from the inside to the outside toward the proximal side.[2] 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.From the results of the simulation tests [1] and [2], the reproducibility of perforation like that of the involved device was confirmed by inserting the guide wire with the catheter bent.Inspection of manufacturing records was conducted.Manufacturing process performs 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 230202990 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 catheter kink was found at near the distal tip.In addition, the tip marker and tip of the involved device were crushed.To clean the involved device, a syringe was used to inject water.However, there was resistance to water injection, and since it could not be injected normally, the involved device could not be cleaned normally.When the kink of the involved device was enlarged and observed, it was perforated with the resin elongation from the inside to the outside and the breakage of the braid.In addition, a foreign substance was found in the lumen at the point of about 7 cm from the distal tip of the involved device.It was inferred that the water injection resistance to the involved device may have been caused by this foreign substance.Based on the occurrence situation provided and appearance observations, it was considered that a thrombus, etc.Were clogged in the lumen of the involved device.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 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.Terumo medical products (tmp)(importer) registration no.2243441 is submitting this report on behalf of terumo clinical supply co., ltd.(manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the involved device passed the intended blood vessel.Upon removal of the involved device, it was found that the guidewire used in combination with it had protruded from a location other than the distal tip of the involved device.

• 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: 17569454
• MDR Text Key: 321669167
• Report Number: 3009500972-2023-00006
• 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: 08/17/2023

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-C785AM
• Device Lot Number: 230202990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2023
• 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