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

Model Number N/A

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

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

Event Date 10/11/2023

Event Type  malfunction  

Event Description

The user facility reported that the involved product was used with a guidewire in combination.After advancing the product to the target blood vessel, when trying to operate the guide wire, the guide wire stopped moving as if it had been trapped.For this reason, an attempt was made to remove the product along with the guidewire, but it seemed to be caught in the guiding catheter as well, and there was a removal resistance of the product.After repeatedly pushing and pulling the product and the guide wire, it was finally able to remove.

Manufacturer Narrative

D2: product code: dqo, kra.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.2243441 is submitting this report on behalf of terumo clinical supply co., ltd.(manufacturer) registration no.3009500972.

Manufacturer Narrative

This report is being sent as follow-up no.1 to provide the completed investigation results.The involved device was returned with the guide wire used in combination inserted.When attempting to remove the guide wire used in combination to clean the involved device, there was resistance, and it could not be removed.For this reason, cleaning fluid could not be injected into the involved device, and cleaning could not be performed normally.Visual inspection was conducted.When we observed the returned involved device, multiple twisted deformations of the catheter were found from approximately 9.0 cm to 11.0 cm from the distal tip of the involved device.In some parts of twisted deformations of the involved device, the braid was exposed.In addition, the catheter crushing was found at the point of 5.7 cm from the distal tip.There were no abnormalities in appearance such as kinks or crushes were observed on the distal part of the involved device.The catheter crushing was found at the point of 5.7 cm from the distal tip.Twisted deformations of the catheter were found from approximately 9.0 cm to 11.0 cm from the distal tip of the involved device.In some parts of this deformation, the braid was exposed.Twisted deformations were found from approximately 9.0 cm to 11.0 cm from the distal tip of the involved device.The simulation test of the twisted deformation that occurred in the involved device was performed by following methods.Sample was a zizai nc-c783am.The method was to set a metal wire with an outer diameter of 0.014 inch (0.36 mm) to the sample.In this state, fix the sample with a torquer.Grasp the torquer and twist it from two directions to apply a load until the catheter undergoes torsional deformation.Results were like the involved device; the sample had twisting deformation and exposed braids.The dimensions of the involved device were measured for the following purposes.Outer diameter measured to check for abnormalities that may cause passage resistance, such as abnormalities in the outer diameter, and to check the catheter for abnormalities that may cause tube deformation, such as thinning of resin.As a result, the outer diameters of the distal and proximal side of the involved device, excluding the damaged parts, were within our standard values and no abnormalities were observed.Inspection of manufacturing records was conducted.In our company, for our product zizai, we perform visual inspection, dimension measurements, and lubricity test, by sampling for each manufacturing lot.In our manufacturing process, we perform visual inspections toward all zizai before assembling to the holder.The device history records of the lot 230202990 were reviewed, there were no abnormalities in the results of each inspection.No lubricity abnormalities, catheter deformation, or abnormalities that could cause removal resistance of the guide wire used in combination were observed.When we observed the returned involved device, multiple twisted deformations of the catheter were found from approximately 9.0 cm to 11.0 cm from the distal tip of the involved device.In some parts of twisted deformations of the involved device, the braid was exposed.In addition, the catheter crushing was found at the point of 5.7 cm from the distal tip.As a result of the simulation test, when a torque load was applied to the catheter, the reproducibility of crushing was obtained like the involved device.As a result of the dimension measurement, the outer diameter of the crushed part was out of our standard value.Next, the outer diameters of the distal and proximal side of the involved device, excluding the damaged parts, were within our standard values and no abnormalities were observed.Based on the past experience, it is known that "zizai" might cause the passage/removal resistance of the guide wire used in combination if the lumen is narrowed due to kink, crushing, or stretching of the catheter.For this reason, in this case as well, it was considered that the lumen was narrowed due to damage such as stretching, crushing, and deformation that occurred in the catheter, and that the removal resistance from the guiding catheter used in combination occurred.In addition, the involved device was twisted and deformed in some parts, and the braid was exposed.This suggests that the exposed braid may have increased frictional resistance and caused the removal resistance from the guiding catheter.However, since multiple damages had occurred in the involved device, it was not possible to identify which part of the damage resulted in the catheter stuck and removal resistance of the guide wire used in combination.Since no abnormalities were found in the manufacturing records of the involved device, it was presumed that multiple damages and the decrease in operability that occurred in the involved device may have occurred during use after shipment from our company.

• 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: 18156971
• MDR Text Key: 328414832
• Report Number: 3009500972-2023-00007
• 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: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• 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-C785AM
• Device Lot Number: 230202990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2023
• 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