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

Model Number N/A

Device Problem Difficult to Remove (1528)

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

Event Date 05/24/2023

Event Type  malfunction  

Event Description

The user facility reported when the involved product was used to advance into the blood vessel, there was resistance to operating the guide wire that was used in combination, and it got stuck.Therefore, when the product was removed, the stuck was released, however, the distal tip of the product remained in the guide wire used in combination.The distal tip of the product was collected using a snare so that it did not remain in the blood vessel.

Manufacturer Narrative

D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: initial reporter name: requested, unknown.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 update section h3, and to provide the completed investigation results.Investigation result: observations during cleaning conducted the involved device, zizai (hereinafter referred to as the "involved device") was returned to tcsc with the guide wire used in combination.The involved device had a catheter torn at a point about 7.5 cm from the distal tip, and it was in a state of being separated into two parts.When the involved device was flushed for cleaning, there was resistance to injection on both the cut distal and proximal sides and could not be properly flushed.For this reason, cleaning fluid could not be filled into the lumen of both cut distal and proximal sides, and cleaning could not be performed normally.X-ray photography of the involved device was conducted.Based on the occurrence situation that was reported, it was considered that the cut guide wire got stuck in the lumen of the involved device.Therefore, based on the x-ray imaging results of the involved device, a radiopaque foreign substance, which is the guide wire piece reported to us, was found in the distal fragment.It was located about 4.0 cm to 6.5 cm from the distal tip of the catheter.Similarly, in the proximal fragment, a radiopaque foreign substance was observed at about 7.8 to 8.3 cm from the distal tip of the fracture.When observing the appearance of the involved device and the guide wire used in combination, the following observations were found.The cut distal side of the catheter had a disarray in the distal tip and marker, and a deformation of a bellows shape occurred up to 1.6 cm from the distal end.In the lumen of the catheter at a point about 5.5 cm from the distal tip of the catheter on the cut distal side, the shadow of a clogged foreign substance was observed.The cut distal side of the catheter was 7.5 cm in total length.Near the cut point, the tube had elongation, flattening and exposed braiding, and it was cut to pieces.The cut proximal side of the catheter was about 154 cm in total length.Like the distal side, near the cut point, the tube had elongation, flattening and exposed braiding, and it was cut to pieces.In the lumen of the catheter at a point about 7.8 cm to 8.3 cm from the cut part of the catheter on the cut proximal side, the shadow of a clogged foreign substance was observed.The guide wire used in combination was cut at a point 203.4 cm from the proximal side.In addition, a kink was observed at a point 30.8 cm from the proximal side.Cut part of the guide wire used in combination.When observing the guide wire used in combination, it was cut at a point of 203.4 cm from the proximal side.When the cut surface was enlarged and observed, it was chipped in one part, however, the cross section was smooth overall and had few irregularities.Inspection of the compatible size was conducted.To check the possibility that the stuck of the guide wire that was used in combination with the involved device was caused by the combination of each device, the outer diameters of our product zizai (trade name: terumo microcatheter) and the guide wire that was used in combination were inspected.As a result, the guide wire, and our product zizai were a usable combination.Dimension measurement of each dimension was measured to check for the following possibilities.Outer diameter: possibility that the lumen of the involved device was narrowed due to crushing of the catheter.As a result of the dimension measurement, the outer diameter of the proximal side of the involved device were within our standard values, and no abnormalities were observed.Other parts could not be measured because the involved device could not be cleaned, or it had crushing.For this reason, as an alternative, the dimensions of the storage sample with the same lot as the involved device were measured.As a result, the dimensions of the storage sample with the same lot were within our standard values, and no abnormalities were observed.Inspection of manufacturing records, in our company, when receiving raw materials for our product zizai, we perform visual inspection and dimension measurements by sampling.In addition, in our manufacturing process, we perform visual inspections toward all zizai before assembling to the holder.The device history records of the lot 221203020 were reviewed, there were no abnormalities that could cause the stuck of the guide wire used in combination and catheter crushing.The presumed cause of the involved device was returned to tcsc with the guide wire used in combination.The involved device had a catheter torn at a point about 7.5 cm from the distal tip, and it was in a state of being separated into two parts.When the involved device was flushed for cleaning, there was resistance to injection on both the cut distal and proximal sides and could not be properly flushed.For this reason, cleaning fluid could not be filled into the lumen of both cut distal and proximal sides, and cleaning could not be performed normally.Based on the x-ray imaging results of the involved device, a radiopaque foreign substance was found in both distal and proximal side.From the occurrence situation that was reported, these radiopaque foreign substances were the guide wire pieces.When observing the appearance of the involved device, both distal and proximal side of the catheter, the tube had elongation, flattening and exposed braiding, and it was cut to pieces.As a result of checking the ifu of our product zizai and measuring the outer diameter of the guide wire used in combination, it was found that each device was a usable combination.As a result of the dimension measurement of the involved device, the outer diameter of the proximal side of the involved device were within our standard values, and no abnormalities were observed.On the other hand, the outer diameters of the distal part and fracture could not be measured due to crushing.The dimensions of the storage sample with the same lot were within our standard values, and no abnormalities were observed.Based on the above results, it was considered that the stuck of the guide wire that occurred in the involved device was caused by narrowing of the lumen due to elongation or deformation of the catheter.Next, it was considered that the cut that occurred in the involved device was caused by the combined guide wire being operated while it was stuck, causing it to stretch and break.In our company, when receiving raw materials for our product zizai, we perform visual inspection and dimension measurements by sampling.In addition, in our manufacturing process, we perform visual inspections toward all zizai before assembling to the holder.The device history records of the lot 221203020 were reviewed, there were no abnormalities that could cause the stuck of the guide wire used in combination and catheter crushing.For this reason, it was considered that appearance damage, including deformation of the catheter, which occurred in the involved device may have occurred after our shipment.

• 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: 17196092
• MDR Text Key: 318214131
• Report Number: 3009500972-2023-00004
• 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: 06/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2023
• 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-C783AM
• Device Lot Number: 221203020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2023
• 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