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 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

A1: patient identifier: requested, not provided a2: age & date of birth: requested, not provided a3: patient sex: requested, not provided a4: weight: requested, not provided a5: ethnicity: requested, not provided a6: race: requested, not provided 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.(b)(4) 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 product was passed through a narrowed calcified blood vessel.Thereafter, when trying to remove the product, there was 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.When observing the appearance of the involved device, the crushing of the tip, the disorder of the gold coil marker and the damage of the outer layer tube were found on the distal part of the involved device.Next, a catheter elongation of 19.4 cm from the distal tip was found on the shaft of the involved device.Also, a deformation of bellows-shape occurred at a place 9.7 cm to 19.4 cm from the distal tip.In addition, deformations of bellows-shape were observed at a place near 21.5 cm and 33.0 cm from the distal tip, and a catheter crushing was observed at place near 31.4 cm from the distal tip.The crushing of the tip, the disorder of the marker and the damage of the outer layer tube were found on the distal part of the involved device.In the involve device, a bellows-shape deformation with the catheter elongation was observed from the distal tip from 9.7 cm to 19.4 cm.Catheter deformations of bellows-shape were observed at a place near 21.5 cm and 33.0 cm from the distal tip.Catheter crushing was observed at a place near 31.4 cm from the distal tip of the involved device.The dimensions of the involved device were measured for the following purposes.Total length was measured to check for elongation that has occurred in the involved device.Inner and outer diameters were measured to check for abnormalities that may cause passage resistance, such as abnormalities in the outer diameter, and to check for abnormalities that may cause tube deformation in the catheter, such as thin resin walls.As a result, the total length and distal part were outside of our standard value due to the deformation that occurred in the involved device.Next, except for the damaged parts, the inner and outer diameters of the distal and proximal side of the involved device 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 220902000 were reviewed, there were no abnormalities in the results of each inspection.No abnormalities that could cause catheter removal resistance and catheter deformation such as stuck, crushing or elongation were observed.When observing the appearance of the involved device, the crushing of the tip, the disorder of the gold coil marker and the damage of the outer layer tube were found on the distal part of the involved device.Next, a catheter elongation of 19.4 cm from the distal tip was found on the shaft of the involved device.Also, a deformation of bellows-shape occurred at a place 9.7 cm to 19.4 cm from the distal tip.In addition, deformations of bellows-shape were observed at a place near 21.5 cm and 33.0 cm from the distal tip, and a catheter crushing was observed at place near 31.4 cm from the distal tip.As a result of the dimension measurement, the total length was outside of our standard value due to the elongation that occurred in the involved device.Next, except for the damaged parts, the inner and outer diameters of the distal and proximal side of the involved device were within our standard values, and no abnormalities were observed.The elongation that occurred in the involved device was starting from the distal tip of involved device.In addition, multiple damages such as the disorder of the gold coil marker occurred on the distal part of the involved device.From this, it was considered that the distal tip of the involved device may have gotten stuck in the blood vessel, and causing elongation and other damages may have occurred due to subsequent operations.We perform visual inspections toward all zizai before the holder assembly in the manufacturing process.As a result of reviewing device history records of the involved device, there were no abnormalities in the results of each inspection.Based on this, it was considered that the several damages that occurred on 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: 18156972
• MDR Text Key: 329101086
• Report Number: 3009500972-2023-00008
• 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-C783AM
• Device Lot Number: 220902000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2022
• 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