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

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 06/29/2022

Event Type  malfunction  

Manufacturer Narrative

Lot number: requested, unknown.Expiration date: unknown due to unknown lot number.Udi: unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date: unknown due to unknown lot number.The actual device has been returned for evaluation.When observing the sample returned, the catheter was cut and there was no marker at the tip.Past experience has shown that the marker may fall off if the catheter is operated with the stopcock not fully open.It has been determined that this complaint is reportable as some of the catheters amputated due to recurrence may remain in the patient's body.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.(b)(4).

Event Description

The user facility reported that the involved progreat device was inserted into the stopcock used together, but it did not enter.Therefore, another microcatheter was newly taken out and used.

Manufacturer Narrative

This report is being submitted as follow-up no.1 to update section h3, and to provide the completed investigation results.As for the involved device, the progreat (hereinafter referred to as the involved device) and the combined three-way stopcock were returned.When observing the appearance of the involved device, the tube was flattened over 0.7 cm from the distal tip.In addition, it was found that the marker and tip were dislodged.When the braid spacing of the involved device and the current progreat was checked, the braid spacing of the involved device was not greatly widen, and no significant elongation was observed in the tube.When the appearance of the combined three-way stopcock was observed, no abnormalities in appearance such as cracking of the resin were observed.By the following methods, simulation tests of the passage resistance to the three-way stopcock and the dislodgement of the marker that occurred in the involved device were performed.In consideration of the fact that detailed information such as the product name and specifications of the combined three-way stopcock could not be obtained, and the possibility of damage due to the simulation test, another product of the same size as the combined three-way stopcock (hereinafter referred to as the three-way stopcock) was used.Sample: progreat cc-m1711s and a three-way stopcock.Method [1]: tilt the cock and prepare three-way stopcocks with the degree of opening adjusted.The cock angles are set at 0°, 10°, and 20°.Insert a progreat with a guide wire into each stopcock and check whether it can be inserted and removed.Method [2]: insert the progreat without a guide wire into the stopcock with the cock angle of 0°.In this state, change the angle of the cock and remove the progreat.Result [1]: when the progreat was inserted into each stopcock, it could be passed through stopcocks with cock angles of 0° and 10° without resistance and removed.At a cock angle of 20°, the guidewire was passed through, but the progreat was not passed due to the resistance.From the position of the distal tip of progreat, it was considered that the tip marker part was caught in the stopcock.Result [2]: when the progreat was inserted into a stopcock with a cock angle of 0° and tilted to a cock angle of 20°, it could be removed without resistance.At a cock angle of 30°, it could be removed while stretching because of the strong resistance.The marker part was caught on the stopcock and dislodged.In addition, when the removal operation was performed with the cock angle slightly decreased from 30°, the shaft of the progreat was not extended, and the marker part was caught on the stopcock and could be removed in a state where the marker part was dislodged.From each result, the reproducibility of the passage resistance to the stopcock and dislodgement of the tip marker occurred depending on the degree of stopcock opening was obtained.However, the reproducibility of the flatness that occurred in the involved device could not be obtained.Result of simulation test (passability inspection to three-way stopcock): method [1] cock angle: 0°, it could be inserted / removed without resistance.Method [1] cock angle: 10°, it could be inserted / removed without resistance.Method [1] cock angle: 20°, the guide wire passed through, but the progreat could not pass because the tip marker was caught.Method [2] cock angle: 0° to 30°, although there was some resistance at the time of removal, it could be removed while stretching.The marker part was caught on the stopcock and dislodged.Method [2] cock angle: 0° to 30°, although there was some resistance at the time of removal, it could be removed while stretching.The marker part was caught on the stopcock and dislodged.Method [2] cock angle: 0° to 30° to 25° to 30°, the catheter was not stretched and was removed with the tip marker dislodging.Each dimension was measured to inspect the following possibilities.Outer diameter of the involved device possibility was that there was an abnormality in the outer diameter of the involved device, and passage resistance was occurred to the combined three-way stopcock.Inner diameter of involved device checked for a possibility of marker dislodgement due to the thinness of catheter.As a result, the proximal inner and outer diameters of the involved device were within our standard values, and no abnormalities were observed.The inner and outer diameters on the distal side of the involved device could not be measured due to significant damage.Next, the inner diameter of the combined three-way stopcock with the cock fully opened was measured and checked whether the dimension might cause a passage resistance of our product progreat.As a result, the inner diameter of the combined three-way stopcock exceeded the outer diameter of the progreat, and it was a value which the progreat passed through.In our manufacturing process, we perform visual inspections toward all progreat before assembling to the holder.Since the lot of the involved device was unknown, we inspected whether there were any manufacturing abnormalities during the past two years that were within the expiration date at the time of use.As a result, no abnormalities that causes the passage resistance to the combined three-way stopcock or dislodgement of the marker was observed.When observing the appearance of the involved device, the tube was flattened, and the marker and tip were dislodged.In the simulation tests, at a cock angle of 20°, the guidewire was passed through, but the progreat was not passed due to the resistance.From the position of the distal tip of progreat, it was considered that the tip marker part was caught in the stopcock.When the progreat was inserted into a stopcock with a cock angle of 0° and tilted to a cock angle of 30°, there was a resistance while removing.When the removal operation was further performed in that state, the progreat could be removed with the marker part dislodged while strongly stretching.In addition, when the removal operation was performed with the cock angle slightly decreased from 30°, the marker part was caught on the stopcock and could be removed in a state where the marker part was dislodged.In these simulation tests, considering the fact that detailed information such as the product name and specifications of the combined three-way stopcock could not be obtained, and the possibility of damage due to the simulation test, the three-way stopcock that is included with our other products was used.From these facts, depending on the degree of the three-way stopcock opening, it was presumed that there are possibilities that the passage resistance at the time of insertion and the dislodgement of the marker part will occur during removal.However, the reproducibility of the flatness that occurred in the involved device could not be obtained.When the inner and outer diameters of the involved device were measured, except for the damaged distal tip, other parts were within our standard values.In addition, the inner diameter of the combined three-way stopcock was the value which our product progreat passed through.From a result of inspection of manufacturing records, it was not found any abnormalities.Based on the above results, it was considered that the passage resistance to the three-way stopcock that occurred in the involved device was caused by the insertion operation when the stopcock was not sufficiently opened.Next for the dislodgement of the tip marker that occurred in the involved device, it was considered that it was caused by the removal operation while the stopcock open state was changed after passing through the three-way stopcock once.Although the reproducibility of the flatness that occurred in the involved device could not be obtained, other findings on the involved device (dislodgement of the marker) suggested that it may have been caused by catheter operation when the stopcock was not fully opened.

• Brand Name: PROGREAT
• Type of Device: MICRO CATHETER SYSTEM
• Manufacturer (Section D): TERUMO CLINICAL SUPPLY CO., LTD.; 3 kawashima-takehaya-machi; 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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 15126816
• MDR Text Key: 304129920
• Report Number: 3009500972-2022-00005
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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: CC-M1715S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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