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

Model Number N/A

Device Problems Difficult to Remove (1528); Stretched (1601); Physical Resistance/Sticking (4012)

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

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

D2: product code: dqo, kra.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.

Event Description

The user facility reported the involved product was passed through a narrowed calcified blood vessel.Thereafter, when trying to remove the product, there was a removal resistance, and the catheter was stretched.There was resistance, but it was eventually removed.

Manufacturer Narrative

This report is being sent as follow-up no.1 to update section h3, and to provide the completed investigation results.The device involved was returned to tcsc, referred to as "zizai." upon examination, we noted a crushing deformation 0.6 cm from the tip, with the front and back of the crushed area appearing flattened.Additionally, the catheter extended approximately 6.8 cm from the distal tip, showing a wider spacing between the braids compared to a normal product.A kink in the catheter was located 0.3 cm from the proximal side.To determine if the failure of the guidewire to pass was due to resistance between the device and the guidewire, the guidewire's passability was assessed using the following sample.Sample: involved device 0.016-inch guidewire radifocus guide wire rg-ea1618s.Method: insert the guidewire from the proximal side of the device, ensuring it is in a straight line, and verify its passability during insertion and removal.Result: insertion of the guidewire from the proximal side resulted in resistance at the point where the guidewire extended approximately 1.0 cm from the distal tip of the device, preventing further advancement.The dimensions of the device in question were measured for specific purposes: total length: this was measured to ascertain any elongation that may have occurred in the device.Inner and outer diameters: these were measured to: (i) identify any irregularities that could impede the passage of the combined guidewire, such as kinks surpassing the standard outer diameter values; (ii) detect any irregularities that could lead to catheter kinking or tube deformation, like resin thinning.As a result, the total length and outer diameter of the distal and kinked parts were outside our standard values due to elongation and crushing in the device.It was inferred that the lumen at the distal and kinked parts of the device was narrowed.Meanwhile, the inner and outer diameters on the proximal side of the device fell within our standard values, with no abnormalities detected.The inner diameter on the distal side was unmeasurable as the pin gauge could not pass through, owing to catheter crushing.For our product, zizai, we conduct visual inspections and dimensional measurements by sampling each manufacturing lot.During our manufacturing process, all zizai units undergo visual inspections before being assembled into the holder.The device history records for lot 230502870 have been reviewed, confirming that there were no irregularities in any of the test results.No issues were found that could lead to resistance in the guidewire's passage or deformation of the catheter.Upon examination of the returned device, a crushed deformation and a flattened area were noted at the distal end.Additionally, the catheter was elongated by approximately 6.8 cm from the distal tip, with the spacing between the braids wider than that of a standard product.A kink in the catheter was identified on the proximal side.During the guidewire passability test, the guidewire became lodged approximately 0.3 cm from the distal tip and failed to traverse through the device.Following the dimension measurement, the outer diameter of the distal and kink parts was outside our standard values due to elongation and crushing in the device.Consequently, the lumen at the distal and kink parts of the device was deemed to be narrowed.However, the inner and outer diameters on the proximal side of the device fell within our standard values, with no abnormalities detected.The inspection of the manufacturing records revealed no irregularities.The results suggest several factors that could have contributed to the increased resistance encountered by the combined guidewire within the device: the lumen of the involved device may have narrowed due to crushing, stretching, or similar actions, potentially increasing the guidewire's passage resistance.The catheter's movement during use, such as navigating through tortuous blood vessels, may have also contributed to increased resistance.It is possible that a combination of these factors led to the heightened resistance during the guidewire's passage.For our product, zizai, we conduct visual inspections and dimension measurements through sampling for each manufacturing lot.Additionally, we perform visual inspections on all zizai units before assembling them into the holder as part of our manufacturing process.Since the manufacturing records of the device in question revealed no abnormalities, it is suggested that any observed defects, such as crushing, may have occurred during usage after the device was shipped 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: 18407235
• MDR Text Key: 331682266
• Report Number: 3009500972-2023-00010
• 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: 12/27/2023

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: 230502870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2023
• 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